Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011191255

FEI Number

3011191255

Entity Name

VIVE Health LLC

City/State/Country

Naples, FL, US

Establishment Address

8955 Fontana Del Sol Way, Naples, FL 34109, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

VIVE Health LLC (Owner Number: 10047487)

Owner / Operator Contact Address

8955 Fontana Del Sol Way, Naples, FL 34109, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K123030

PMA Number

N/A

All Registered Proprietary Names

Power Wheelchair Model C Power Wheelchair FloTilt Power Wheelchair MOB1138 Sterno-Costal Orthosis 456 TLSO Rib Brace 464 TLSO C.A.S.H Orthosis Sport Wheelchair Mobility Scooter Series A MOB1053 Arch Supports Walker Boot Air Pro (Short) 1930 AFO Bunion Splint Ankle Wraps 4386 Short Walker Boot Ankle Sleeves with Straps Walker Boot Air Pro (Tall) Arm Protection Sleeves Walker Boot Pro (Tall) Ankle Air Stabilizer Anterior Carbon Fiber AFO Quick Lace Ankle Brace 350 Ankle Air Splint 4386 Standard Walker Boot ROM Walking Boot Felt Arch Pads Dorsal Night Splint Laced Ankle Brace Exo Walker Boot Achilles Wedge 971 Ankle Brace 386 Walker Boot Air Ankle Splint Heel Pillows Ankle Air Splint Motion Ankle Brace Pneumatic Walking Boot Walker Boot Pro (Short) Air CAM Walker Boot 1906 Motion Ankle Brace Air Stirrup Ankle Brace CAM Walker Boot 360 Walker Boot Hip and Knee Recovery Kit Sock Removal Aid Dressing Stick Sock Assist and Remover Shoe Remover Sock Assist Bendable Sock Asssit Button Hook TeleRPM Pulse Oximeter 4G Cold Massage Roller Ball Sensory Rings Compact BPM Heating Pads Extending Wheelchair Arm Rests Height Adjustable Wheelchair Arm Rests ROM Hip Brace Blood Glucose Test Strips Blood Glucose Monitor DMD1079 Individual Toe Caps Hammer Toe Splint Plantar Fasciitis Stretch Splint Toe Wrap Toe Pouches Bunion Protector 3 Layer Toe Separators Toe Sleeves Dual Calf Stretcher Toe Spacers Toe Separators Bunion Kit Ergonomic Toe Separators Little Toe Sleeves Gel Bunion Sleeve Gel Metatarsal Sleeves Gel Heel Protectors Ostomy Support Belt Ostomy Adhesive Barrier Ring Ostomy Adhesive Barrier Ostomy Bag Clamps Ostomy Adhesive Barrier Strip Leg Rest Heel Loop Brake Handle Extensions DMD1013 Sphygmomanometer Triple Toe Splint Double Toe Splint Silicone Heel Cups U Shaped Felt Callus Pads Toe Splint Ostomy Scissors Rise Up Toilet Rail Bariatric Commode Folding Commode Folding Shower Chair Compact Toilet Rail Stand Alone Toilet Rail Easy Rinse Shower Chair Sliding Shower Chair Toilet Safety Frame with Handles Bed Rail Toilet Safety Rail Transfer Bench Shower Chair Toilet Riser Shower Chair Toilet Safety Frame Stand Assist Height Adjustable Bed Rail Bathtub Rail Shower Commode Transport Chair Bariatric Shower Chair Crutches Forearm Crutches Portable Oxygen Concentrator LVA3117 Portable Oxygen Concentrator Juniper AC Adapter Portable Oxygen Concentrator Juniper External Battery Charger Portable Oxygen Concentrator Juniper Nasal Cannula Portable Oxygen Concentrator Juniper Filters Portable Oxygen Concentrator Juniper DC Charger Portable Oxygen Concentrator Juniper Carry Bag Portable Oxygen Concentrator Juniper Sieve Bed Portable Oxygen Concentrator Juniper Battery Portable Oxygen Concentrator Juniper AC Power Cord Elbow Compression Sleeve Waist High Compression Pantyhose 15-20mmHg Knee High Anti Embolism Stockings 15-20mmHg Compression Wrist Wrap Knee Sleeves Thigh High Anti Embolism Stockings 15-20mmHg Knee High Compression Stockings 15-20mmHg Leg Compression Sleeve Multi Purpose Support Wraps Finger Sleeves Thigh High Open Toe Compression Stockings 15-20mmHg Wrist Compression Sleeve Knee High Compression Stockings 20-30mmHg Calf Compression Sleeve Arm Compression Sleeve Compression Knee Sleeve Thigh High Compression Stockings 15-20mmHg Knee Brace Undersleeve Thigh Compression Sleeve Blood Pressure Monitor Smart Phone Compatible DMD1092 DMD1094 Wound Cleanser Gel Thumb Support Palm Protector with Finger Separators Resting Hand Splint Finger Splint 807 Thumb Splint Dual Finger Splint Finger Grip Brace Dual Trigger Finger Splint Advanced Wrist Brace Wrist Wraps Overnight Wrist Brace Boxer Splint Extended Trigger Finger Splint Trigger Finger Splint Quick Lace Wrist Brace Thumb Brace 908 Wrist Splint Standard Thumb Brace Quick Lace Thumb Brace Trigger Finger Splint Brace Palm Protectors Tunnel Tamer Thumb Spica Carbon Crossover Power Wheelchair MOB1123 Copper Full Finger Arthritis Gloves Arthritis Gloves with Grips Arthritis Gloves Full Finger Arthritis Gloves Copper Arthritis Gloves Fingerless CPAP Hose Oral Thermometer RHB1043 Tens Digital Massager 3-Wheel Scooter MOB1025 Easy Twist Lancets Toilet Seat Riser Padded Commode Toilet Seat Riser with Arms Reclining Shower Commode Transport Chair Bariatric 4-in-1 Commode and Shower Chair Folding Commode Raised Toilet Seat CoreTech Compression System (RHB3003) Denture Cleaning Tablets Blood Pressure Monitor DMD1001 Tens Unit Replacement Patch Zippered Knee High Compression Stockings 15-20mmHg Knee High Compression Stockings 30-40mmHg Knee High Men's Compression Dress Socks 15-20mmHg Knee High Compression Stockings Thigh High Compression Stockings 20-30mmHg Zippered Knee High Compression Stockings 20-30mmHg Sports Compression Socks Waist High Compression Pantyhose 20-30mmHg Knee High Open Toe Compression Stockings 20-30mmHg Knee High Men's Compression Dress Socks 20-30mmHg Knee High Open Toe Compression Stockings 15-20mmHg MOB1030 Folding Mobility Scooter MOB1027 4-Wheel Mobility Scooter MOB1053 Mobility Scooter - Series A MOB1025 3-Wheel Mobility Scooter Pediatric Wheelchair MOB1145 Reclining Pediatric Wheelchair MOB1146 Heel Lift Inserts Arch Support Sheepskin Insoles Heel Cups Shock Absorbing Heel Cup Heavy Duty Gel Insoles Carbon Fiber Insoles Heavy Duty Insoles Arch Support Gel Insoles Memory Foam Insoles High Heels Insoles Wrist BPM DMD1063 3 Wheel Mobility Scooter 4 Wheel Mobility Scooter MOB1137 Mobility Scooter MOB1029L Large Power Wheelchair MOB1054 Electric Wheelchair Model: V MOB1029S Small Power Wheelchair Pediatric Compressor Nebulizer (Bear) Lift Chair Handheld Massager Adhesive Remover Wipes AirCarbon Power Wheelchair MOB1140 Oral Thermometer Large Display Moist Heat Pack Comfort+ Nasal CPAP Mask Frame Comfort+ Full Face CPAP Mask Headgear Classic Nasal Pillows CPAP Mask Headgear Comfort+ Full Face CPAP Mask Headgear with Clip Comfort+ CPAP Mask Soft Sleeves Fit Packs Oxygen Concentrator Port CPAP Mask Clips Classic Nasal CPAP Mask Frame Classic Full Face CPAP Mask Frame Comfort+ Full Face CPAP Mask Cushion Comfort+ Full Face CPAP Mask Frame Classic Nasal CPAP Mask Classic Full Face CPAP Mask Comfort+ Nasal CPAP Mask Classic Nasal Pillows CPAP Mask Frame Comfort+ Nasal CPAP Mask Headgear with Clip Classic Nasal CPAP Mask Headgear with Clip Classic Nasal Pillows CPAP Mask Cushion Comfort+ Nasal CPAP Mask Cushion Comfort+ Nasal CPAP Mask Tubing 18 CPAP Mask Swivel Comfort+ Nasal CPAP Mask Headgear Classic Full Face CPAP Mask Headgear with Clip Classic Nasal CPAP Mask Headgear Comfort+ Full Face CPAP Mask Classic Full Face CPAP Mask Headgear Classic Full Face CPAP Mask Cushion Classic Nasal Pillows CPAP Mask Classic Nasal Pillows CPAP Mask Headgear with Clip Classic Nasal CPAP Mask Cushion Tube Alternating Pressure Pad 5" Alternating Pressure Pad Full Alternating Pressure Pad System Alternating Pressure Seat Pad Alternating Pressure Pad Standard Alternating Pressure Pad Alternating Pressure Pad Replacement Low Air Loss Mattress 8" Low Air Loss Alternating Pressure Mattress Lateral Rotation 8" Low Air Loss Alternating Pressure Mattress 8" Power Wheelchair Model C MOB1094 Dual Thermometer Therapy Bar Hand Exercise Eggs Shoulder Pulley Hand Contracture Orthosis Kit Shoulder Pulley With Fabric Hook Finger Ladder Shoulder Pulley With Ergonomic Grip Stretch Strap Calf Stretcher Mobilization Belt Hand Exercise Balls Hand Extension Exercisers Wrist Sleeves Multi Purpose Support Wraps Push-Button Safety Lancets 30G Push-Button Safety Lancets 28G EMS TENS Unit RHB2026 Gel Mattress Overlay Foot Bar Elevating Leg Rest Air Frame Wheelchair MOB1062 Portable Oxygen Concentrator Juniper Pro Sieve Bed Juniper Pro 6 Setting Portable Oxygen Concentrator LVA3111 Portable Oxygen Concentrator Juniper Pro Filler Kit (int. and ext.) Portable Oxygen Concentrator Juniper Pro DC Charger Portable Oxygen Concentrator Juniper Pro AC Power Cord Portable Oxygen Concentrator Juniper Pro AC Adapter Portable Oxygen Concentrator Juniper Pro Carry Bag Juniper 5 Setting Portable Oxygen Concentrator LVA3161 Portable Oxygen Concentrator Juniper Pro External Battery Charger Portable Oxygen Concentrator Juniper Pro Battery Transparent Film Dressing Medical Paper Tape Wound Closure Kit (Sterile) Kinesiology Tape Pre-Wrap Tape Surgical Tape Standard Blood Pressure Monitor DMD1087 Bariatric Wheelchair MOB1141 Heavy Duty Wheelchair MOB1078 Heavy Duty Wheelchair MOB1150 Island Dressing Hydrocolloid Roll Hydrocolloid Bordered Dressing (Sterile) Hands Free Breast Pump (Model S21) Patient Lift U Sling Sock and Shoe Assist Stand Assist Seat Stand Assist Handle Transfer Disc Tubular Slide Sheet Leg Lift Assist Angled Stocking Donnor Car Assist Strap Leg Lifter Bed Step Assist Lift Sling with Opening Suction Grab Bar Step Stool with Handrail Transfer Belt Transport Stand Assist Sock Assist and Remover Chair Transfer Sling Transfer Sling Portable Stand Assist Multi Purpose Leg Lifter Wooden Transfer Board Patient Lift Sling Multi Grip Leg Lifter Floor To Ceiling Grab Bar Transfer Belt with Handles Plastic Buckle Easy Clean Transfer Belt Transfer Belt Metal Buckle Patient Lift Toilet Sling Thigh Lifter Car Assist Handle Stand Assist Transfer Disc Spill Proof Scoop Bowl Transfer Blanket Step Stool Transfer Belt Plastic Buckle Bed Ladder Air Frame Aluminum Power Wheelchair MOB1107 639 LSO Pro 464 TLSO Pro 456 TLSO Pro 456 TLSO Back Brace 3 in 1 Step Down LSO 626 LSO Pro 637 LSO Pro 637 LSO Essential 627 LSO Essential 627 LSO Pro Cross Support Back Brace 627 LSO Ultra Hernia Belt 639 LSO Ultra 625 Back Brace 631 LSO Pro 637 LSO Ultra 621 SI Belt 631 LSO Essential Industrial Bace Brace 626 LSO Ultra 631 LSO Ultra Posture Corrector 626 LSO Essential SI Belt Long Handled Toe Washer Kit Scoliosis Brace Urinary Drainage Bags (Leg) Urinary Drainage Bags (Bedside) Blood Pressure Monitor DMD1068 Pulse Oximeter Compatible with Smart Devices DMD1046 8 Mode TENS Unit RHB1006 760 ROM Elbow Brace The Bolt Shoulder Stabilizer Stabilizing Elbow Brace Shoulder Brace Cross Support Humeral Fracture Splint (Upper) Humeral Fracture Splint (Lower) Hand and Wrist Immobilizer ROM Elbow Brace Post Op Shoe Round Toe Shoe Lift Balancer Envelop - 3/4 Length Plantar Plus - Full Length Insoles Bunion Protector Gel Heel Cups Plantar Series - 3/4 Length Insoles Envelop - Full Length Gel Post Op Shoe Loop Toe Spacers (8 Pack) Plantar Series - Full Length Insoles Envelop Full Length Bluetooth Pulse Oximeter Electric Wheelchair Model V MOB1054 Wireless Tens Unit RHB1006 Muscle Massager TENS Unit 8 mode Catheter Bag Holder Catheter Leg Bag Straps Catheter Leg Bag Holder Sleeves Air Frame Power Wheelchair - Magnesium Collection MOB1125 Offset Cane Soft Grip Carbon Fiber Standing Cane Offset Cane Aluminum Bariatric Cane LED Folding Cane Offset Bariatric Cane Folding Offset Cane Stand Assist Cane Stair Assist Cane Carbon Fiber Cane Walking Cane with Seat Folding Cane Quad Cane Carbon Fiber Quad Cane Folding Offset Swivel Cane Cane with Seat Full Chair Incontinence Pads Disposable Underpads Chair Incontinence Pads Cast Tape Silicone Scar Tape King Neptune Mobility Scooter MOB1128 TeleRPM BPM TeleRPM Blood Pressure Monitor Replacement Cuff XL TeleRPM Blood Pressure Monitor Replacement Cuff Large CPAP Hose Patella Strap Knee Immobilizer Offloader Elite OA CoreWrap Hinged Knee Wrap Stabilizing Knee Sleeve ITB Brace ACL Knee Brace SAFS 397 Suspension Sleeve Groin Support Groin Brace Sciatica Calf Brace Offloader Elite Wrap Single Panel Knee Immobilizer Tri Panel Knee Immobilizer Knee Brace ROM Knee Brace OA Knee Brace Calf Brace Hinged Knee Brace CoreTrack Patellar Stabilizer ROM Hinged Knee Brace Elbow Brace Offloader Knee Wrap ROM Elbow Brace Dual Patella Strap Heavy Duty Hinged Knee Brace ROM Knee Brace Elite Universal Knee Brace Tennis Elbow Strap Knee Support Posture Corrector Compression Bicep Strap Thigh Brace Shin Wrap Dual Offloader Easy Clean Wheelchair Armrest Wheelchair Gel Set Cushion Oxygen Cylinder Shoulder Bag Wheelchair Seatbelt Air Seat Cushion Solid Seat Insert Foldable Full Wheelchair Cushion Foldable Wheelchair Cushion Lateral Wheelchair Armrest Wheelchair Backrest Cushion Wheelchair Bag Wheelchair Harness (Waist and Pelvic) Torso Support Wheelchair Harness Wheelchair Footrest Extender Wheelchair Armrests Memory Foam Wheelchair Cushion Rollator Seat Bag Wheelchair Cushion Under Seat Wheelchair Harness Walker Basket Power Wheelchair Seat Cover and Cushion Rollator Bag Waist and Pelvic Wheelchair Harness Rollator Travel Bag Wheelchair Tray Ergonomic Rollator Bag Oxygen Tank Holder Dual Mobility Scooter Seat Bag Mesh Wheelchair Bag Sheepskin Wheelchair Seat and Backrest Pads Walker Bag Oxygen Cylinder Bag Oxygen Tank Holder Mobility Side Bag Easy Clean Wheelchair Cushion Air Frame Rollator Carry Bag Body Fat Scale Compatible with Smart Devices Digital Tens Unit Lightweight Arm Cast Cover Lightweight Leg Cast Cover Leg Cast Cover Waterproof Arm Cast Cover Arm Cast Cover Arm Cast Cover Protection Tall Arm Cast Cover Protection Short 960 Advanced Arm Sling 670 Arm Sling 670 Advanced Arm Sling 670 Universal Arm Sling 916 Wrist Brace BPM DMD1038 Transport Wheelchair Core Transport Wheelchair Air Frame Wheelchair Shower Commode Transport Chair Core Shower Commode Transport Wheelchair Lightweight Transport Wheelchair Drain Sponge Gauze Rolls Gauze Pads Neptune Mobility Scooter MOB1126 Wrist Brace Mobility Scooter (King Neptune) DMD1017 Stethoscope RHB2026 EMS Tens Unit Vertical Rocker Knife Nosey Dysphagia Cup Plate Guard One Pull Can Opener Stainless Steel Weighted Utensil Set Spill Proof Drinking Cup Spill Proof Scoop Plate Waterproof Shower Protector Patch Super Absorbant Wound Dressing Calcium Alginate Dressing Gelling Fiber Wound Dressing Lidocaine Patches 4% Non Adherent Pads Hydrocolloid Bordered Dressing Compressor Nebulizer Kit, Disposable Aerosol Mask for Nebulizer Compressor Nebulizer Air Filter Compressor Nebuliser Kit, Reusable Compressor Nebulizer Silver Alginate Dressing Pediatric Compressor Nebulizer Compressor Nebulizer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2026-03-20
IPT	Orthosis, Thoracic	Physical Medicine	Class 1	890.3490	2025-12-23
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2026-03-16
INI	Vehicle, Motorized 3-Wheeled	Physical Medicine	Class 2	890.3800	2026-03-20
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2022-11-16
ILD	Adaptor, Dressing	Physical Medicine	Class 1	890.5050	2025-07-28
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2025-11-21
LYG	Massager, Therapeutic, Manual	Physical Medicine	Class 1	890.5660	2025-07-28
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2018-10-05
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2018-10-05
IML	Armrest, Wheelchair	Physical Medicine	Class 1	890.3920	2025-08-11
ITS	Joint, Hip, External Brace	Physical Medicine	Class 1	890.3475	2026-03-12
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2026-03-16
OHI	Orthosis, Foot Drop	Physical Medicine	Class 1	890.3475	2025-07-16
EXE	Protector, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2026-03-04
IMW	Brake, Extension, Wheelchair	Physical Medicine	Class 1	890.3920	2026-03-20
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2019-12-19
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2025-07-16
JOK	Scissors, Medical, Disposable	General Hospital	Class 1	880.6820	2025-12-01
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2025-07-28
IPR	Crutch	Physical Medicine	Class 1	890.3150	2026-03-05
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2026-03-05
FQL	Stocking, Medical Support (For General Medical Purposes)	General Hospital	Class 1	880.5780	2026-03-12
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2026-02-20
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2025-11-21
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2025-05-13
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2026-03-05
IRP	Massager, Powered Inflatable Tube	Physical Medicine	Class 2	890.5650	2025-07-07
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2026-03-12
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2025-07-28
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2018-10-05
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2022-11-09
NYN	Stimulator, Electrical, Transcutaneous, For Arthritis	Neurology	Class 2	882.5890	2022-11-09
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2022-11-09
INI	Vehicle, Motorized 3-Wheeled	Physical Medicine	Class 2	890.3800	2019-12-19
QRK	Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2026-03-19
QRL	Multiple Use Blood Lancet For Single Patient Use Only	General, Plastic Surgery	Class 2	878.4850	2026-03-19
INB	Attachment, Commode, Wheelchair	Physical Medicine	Class 1	890.3920	2025-07-16
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2025-08-11
EFT	Cleanser, Denture, Over The Counter	Dental	Class 1	872.3520	2026-03-05
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2026-03-31
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2017-10-05
DWL	Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)	General Hospital	Class 2	880.5780	2019-12-19
INI	Vehicle, Motorized 3-Wheeled	Physical Medicine	Class 2	890.3800	2019-12-19
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2026-03-16
KYS	Insoles, Medical	General Hospital	Class 1	880.6280	2025-07-16
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2026-02-20
INI	Vehicle, Motorized 3-Wheeled	Physical Medicine	Class 2	890.3800	2026-03-05
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2019-12-19
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2026-03-05
INO	Chair, Positioning, Electric	Physical Medicine	Class 2	890.3110	2019-12-19
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2025-05-13
KOX	Solvent, Adhesive Tape	General, Plastic Surgery	Class 1	878.4730	2026-03-12
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2026-03-05
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2017-10-05
IMA	Pack, Heat, Moist	Physical Medicine	Class 1	890.5730	2026-03-12
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2025-07-16
FNM	Mattress, Air Flotation, Alternating Pressure	General Hospital	Class 2	880.5550	2018-10-05
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2026-03-05
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2018-11-12
IOD	Components, Exercise	Physical Medicine	Class 1	890.5350	2026-02-25
ILG	Stocking, Elastic	Physical Medicine	Class 1	890.3475	2026-03-12
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2026-03-23
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2026-03-12
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2026-03-12
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2026-03-12
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2026-03-12
IKY	Mattress, Flotation Therapy, Non-Powered	General Hospital	Class 1	880.5150	2026-03-19
IMM	Footrest, Wheelchair	Physical Medicine	Class 1	890.3920	2025-08-11
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2026-03-05
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2025-08-28
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2026-03-11
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2026-03-19
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2026-03-19
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2026-03-17
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2026-05-06
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2018-05-22
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2026-03-05
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2025-05-13
ILW	Adaptor, Grooming	Physical Medicine	Class 1	890.5050	2026-03-20
MRI	Orthosis, Truncal/Orthosis, Limb	Physical Medicine	Class 1	890.3490	2026-03-17
FAQ	Bag, Urine Collection, Leg, For External Use, Sterile	Gastroenterology, Urology	Class 1	876.5250	2025-08-13
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2026-03-19
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2026-03-16
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2026-03-05
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2026-03-05
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2025-12-01
KNP	Orthosis, Corrective Shoe	Physical Medicine	Class 1	890.3475	2025-07-14
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2018-10-05
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2026-03-20
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2018-10-05
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2018-10-05
QGC	Suprapubic Catheter Accessories	Gastroenterology, Urology	Class 1	876.5100	2026-03-05
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2026-03-05
IPS	Cane	Physical Medicine	Class 1	890.3075	2025-05-13
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	2025-07-28
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2026-03-12
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	2026-03-12
INI	Vehicle, Motorized 3-Wheeled	Physical Medicine	Class 2	890.3800	2026-03-05
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2026-02-20
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2026-06-18
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2022-11-09
KNO	Accessories, Wheelchair	Physical Medicine	Class 1	890.3910	2025-07-28
PUH	Analyzer, Body Composition, Exempt	Cardiovascular	Class 2	870.2770	2019-12-19
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2018-10-05
KIA	Cover, Cast	General Hospital	Class 1	880.6185	2026-03-11
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2026-03-12
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2018-10-05
INM	Chair, With Casters	Physical Medicine	Class 1	890.3100	2026-03-05
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2025-12-01
INI	Vehicle, Motorized 3-Wheeled	Physical Medicine	Class 2	890.3800	2026-03-05
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2026-03-12
INI	Vehicle, Motorized 3-Wheeled	Physical Medicine	Class 2	890.3800	2025-07-28
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2022-11-09
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2022-11-09
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2022-11-09
ILC	Utensil, Eating	Physical Medicine	Class 1	890.5050	2025-12-05
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2024-08-28
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2025-07-07
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2026-03-12
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2025-07-07

Official Correspondent

Joseph Fleming

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

VIVE Health LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K853594	Vessa , Ltd.	VESSA FLIVVA	1985-09-24
K142783	Heartway Medical Products Co., Ltd.	HEARTWAY Electrically Powered Wheelchair P27	2015-06-12
K935211	Brookefield Hunter, Inc.	WALK N CHAIR	1994-02-02
K832685	Health America	WHEELCHAIR-VARIOUS MODELS	1983-09-20
K903523	Hewlett-Packard Co.	HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE	1990-10-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0005-2018	Permobil, Ab Arvaltsvagen 10	2	Electric Wheelchairs: a) C300 CORPUS II b) C350 CORPUS II c) C400 CORPUS II d) C400 CORPUS II LR e) C500 CORPUS II f) C500 CORPUS II LR
Z-0006-2018	Permobil, Ab Arvaltsvagen 10	2	Electric Wheelchair bases: a) C300 b) C350 c) C400 d) C500
Z-0039-2007	Eagle Parts and Products	2	Eagle Parts and Products Model 624EZ Power Wheel Chairs with internally threaded wheel mount motors.
Z-0040-2007	Eagle Parts and Products	2	Eagle Parts and Products Model 624Mini Power Wheel Chairs with internally threaded wheel mount motors.
Z-0036-2007	Medline Industries Inc	2	Medline Strider Maxi 3 Scooter; a three wheeled battery operated scooter; manufactured by KYMCO, Kaohsiung, Taiwan for Medline Industries, Inc., One Medline Place, Mundelein, IL 60060 USA; model MDS807600 - red and MDS807600B - blue

Similar Registrations

Registration Number	Establishment Name	Location
3045076265	BEIJING ORIONSTAR TECHNOLOGY CO., LTD.	Beijing, CN
3006160539	LOH ENTERPRISES, LLC	Clarks Summit, PA, US
3002667030	TUNG KENG ENTERPRISE CO., LTD.	Taichung City, TW
3043165991	HEBEI DANSONG MEDICAL TECHNOLOGY CO., LTD.	SHIJIAZHUANG Hebei, CN
3036988603	SHENZHEN YATTLL INDUSTRY CO., LTD	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011191255. Last updated year: 2026. Please use registration number 3011191255 when referencing this establishment in official correspondence.