HENGSHUI GANGSHENG MEDICAL INSTRUMENTS CO., LTD

FDA Device Registration & Listing · Hengshui Hebei, CN · Registration 3013856565

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3013856565
FEI Number
3013856565
Entity Name
HENGSHUI GANGSHENG MEDICAL INSTRUMENTS CO., LTD
City/State/Country
Hengshui Hebei, CN
Establishment Address
1000 meters South of Dadi Town Government, Dadi village, Dadi Town, Shenzhou City, Hengshui Hebei 053800, CN
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer),Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device
Owner / Operator
Hengshui Gangsheng Medical Instruments Co., Ltd (Owner Number: 10056289)
Owner / Operator Contact Address
1000 meters South of Dadi Town Government, Dadi village, Dadi Town, Shenzhou City, Hengshui, CN-HE 053800, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Air mattress Externa - Ankle Brace With Air Bag Knee Protector (knitted); Knee Protector (Sport); Inflatable Ankle Support Inflatable, Knee Brace; Knee Support; Knee Protector; Knee sleeve; Knee lmmobilizer; Knee Wrap; Hinged Knee Support Enhanced Knee Brace; OA Knee Brace: Rom Knee Support: Leg Protector: Patella Strap; Patella Support: Patella Open Knee Brace: Adjustable knee Brace: leg Knee Support Sport knee Protector: Orthopedic Orthosis, Rib Fracture, Rib Belt, Prosthetic Suspension Belt Medical Elastic Lumbostad Corset; Waist Brace; Waist Support; Waist Protector; Waist Protector Lumbar Brace; Drawstring Lumbar Brace; Lumbar Extender; Lumbar Protector; Lumbar Support; Elbow Support, Elbow Brace Face shield Mask Protective face shield Long Thumb Spica; Thumb Brace; Palm Protector: Distal Metacarpal Brace Fist Metacarpal Brace: Middle Metacarpal Brace; Proximal Metacarpal Bone Brace; Short Thumb Spica; Wrist Splint; Palm Splint; Palm Support; Palm Brace; Finger Splint; Hand Finger Splint; Hinged Infusion Splint; Walker Boot Wrist Splint; Wrist Wrap; Hand Support; Thumb Support; Thumb Stabilizer Braces; Toe Brace/Protector: Hallux Valgus Brace: Knee Brace: Knee Ankle Foot Orthosis; Leg Brace; Leg Protector; Calf Support; Hip Joint Brace; Hip Resistance Bands; Thigh Support; Thigh Trimmer; Toe Brace: Teo Protector: Hallux Valgus Brace: Waist Brace: Waist Support; Arm Trimmer Elbow Brace: Elbow Support; Shoulder Abduction Brace; Shoulder Support; Rom Shoulder Brace; Wrist Brace; Wrist Support; Inflatable Emergency Splint: Roll Type Splint; Night Splint; Medical Splint Shoulder brace, Shoulder pad, Shoulder wrap Hip joint orthosis, Hip support, Hip brace, Hip knee support Disposable isolation gown tourniquet Wrist Brace: Wrist Support; Adjustable Wrist Brace; Night Wrist Support (Palm Wrist Brace); Wrist Protector Walker, Rollator, Walking Aid Disposable gloves Electric Over Blanket; Far Infrared Heating Pad; Foot Warming Pad; Heat Therapy Knee Wrap; Heated Ankle Support Brace; Pad, Heating, Powered(Back Recovery Wrap; Electric Foot Warmer; Electric Heating Jacket; Electric Heating Pad; Heating Hand Pad; Heating Jacket; Heating Knee; Heating Knee Brace; Heating Knee Pad; Heating Kneepad; Heating Pad; Heating Pad for Abdomen Period Pain Relief; Heating Pad for Neck and Shoulders; Heating Pad Wrap; Heating Shoulder Pad; Heated Shoulder Wrap; Heated Socks; Heated Therapy Elbow Wrap; Heated Vest; Heated Waist Support Belt; Heated Wrap; Heated/Heating Shoulder Support; Heating Belt; Heating Blanket; Heating Eye Mask; Heating Foot Pad; Heating Gloves; Infrared Light Heating Knee Pad; Infrared Light Heating Wrist Brace; Infrared Light Heating Wrist Brace; Heating Slippers; Heating Vest; Heating Waist Belt; Heating Waist Wrap; Heating Wrist Brace; Heated Back Cushion; Heated Belt; Heated Cervical Pillow; Heated Gloves; Heated Jacket; Heated Kneepad; Heated Pad; Infrared Light Therapy Belt; Neck and Shoulder Heating Pad; Powered Heating Pa) Wrist support, Elbow Brace; Wrist Brace; Palm Guard Hand crutch Bandage, Elastic bandage, Elastic Crepe Bandage, Gauze Bandage (Gauze Rol), Mesh Bandage Cervical Traction Belt, Neck Stretcher Hammock, Neck Stretching Fixation Belt, Neck Stretcher Cervical Neck Traction Device, Cervical Neck Traction Device, Neck Cone Traction, Neck Hanging Hernia Belt Support Sling, Arm - Arm Sling Arm Abduction, Shoulder Abduction, Arm Shoulder Abduction Brace, Shoulder Sling (Forearm sling) Tennis Elbow Support: Elbow Brace: Adjustable Elbow race: Arm Band Elbow Protector; Elbow Sleeve; Arm Support, Back Posture Corrector; Back Support Belt; Shoulder Brace; Clavicle Brace; Upper Back Clavicle Brace; Body Pillow; TLSO Back Posture 0rthosis: Back Support; Back Brace; Posture Corrector: Adjustable Posture Corrector;

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FMR Device, Transfer, Patient, Manual General Hospital Class 1 880.6785 2017-11-25
ITQ Joint, Knee, External Brace Physical Medicine Class 1 890.3475 2017-11-25
IPX Orthosis, Rib Fracture, Soft Physical Medicine Class 1 890.3490 2017-11-25
IQE Orthosis, Lumbar Physical Medicine Class 1 890.3490 2023-01-05
IRD Joint, Elbow, External Limb Component, Mechanical Physical Medicine Class 1 890.3420 2023-11-09
QKR Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua Unknown Class N N/A 2020-04-22
ILH Splint, Hand, And Components Physical Medicine Class 1 890.3475 2023-11-09
KNP Orthosis, Corrective Shoe Physical Medicine Class 1 890.3475 2023-01-05
IQI Orthosis, Limb Brace Physical Medicine Class 1 890.3475 2023-11-09
NOC Splint, Extremity, Non-Inflatable, External, Non-Sterile General, Plastic Surgery Class 1 878.3910 2017-11-25
IQQ Joint, Shoulder, External Limb Component Physical Medicine Class 1 890.3420 2023-11-09
IOZ Splint, Abduction, Congenital Hip Dislocation Physical Medicine Class 1 890.3665 2023-11-09
OEA Non-Surgical Gown General, Plastic Surgery Class 1 878.4040 2020-04-22
GAX Tourniquet, Nonpneumatic General, Plastic Surgery Class 1 878.5900 2017-11-25
ISZ Unit, Wrist, External Limb Component, Mechanical Physical Medicine Class 1 890.3420 2023-11-09
ITJ Walker, Mechanical Physical Medicine Class 1 890.3825 2017-11-25
IWP Radiographic Protective Glove Radiology Class 1 892.6500 2020-04-22
IRT Pad, Heating, Powered Physical Medicine Class 2 890.5740 2025-12-09
KFT Assembly, Shoulder/Elbow/Forearm/Wrist/Hand, Mechanical Physical Medicine Class 1 890.3420 2023-11-09
IPS Cane Physical Medicine Class 1 890.3075 2017-11-25
FQM Bandage, Elastic General Hospital Class 1 880.5075 2017-11-25
FPO Stretcher, Wheeled General Hospital Class 2 880.6910 2024-12-12
EXN Support, Hernia Gastroenterology, Urology Class 1 876.5970 2020-12-29
ILI Sling, Arm Physical Medicine Class 1 890.3640 2021-11-10
IOY Support, Arm Physical Medicine Class 1 890.3475 2023-11-09
MRI Orthosis, Truncal/Orthosis, Limb Physical Medicine Class 1 890.3490 2023-11-09

Official Correspondent

XinYing Liu

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Hengshui Gangsheng Medical Instruments Co., Ltd
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
K881862 Thermo Body Wrap Systems, Inc. THERMO-BODY-WRAP SYSTEM 1988-10-13

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0023-05 Stryker Medical 2
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013856565. Last updated year: 2026. Please use registration number 3013856565 when referencing this establishment in official correspondence.
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