COMPASS HEALTH BRANDS (CORPORATE OFFICE)

FDA Device Registration & Listing · Middleburg Heights, OH, US · Registration 3012316249

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
3012316249
FEI Number
3012316249
Entity Name
COMPASS HEALTH BRANDS (CORPORATE OFFICE)
City/State/Country
Middleburg Heights, OH, US
Establishment Address
6753 Engle Rd, Middleburg Heights, OH 44130, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Compass Health Brands (Corporate Office) (Owner Number: 2182780)
Owner / Operator Contact Address
6753 Engle Rd, Middleburg Heights, OH 44130, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K091040
PMA Number
N/A

All Registered Proprietary Names

Richmar Cylinder Stand ROSCOE MEDICAL T7 Massager Richmar COMPASS HEALTH BRANDS Aid(s) for Daily Living Meridian XMAS TREE O2 ADPTR Apex Richmar Compass Health Brands Carex Health Brands DT7308 TENS 7000 Migraine Pain Relief pack, hot or cold, disposable Apex Pill Organizers Richmar Aspirator, High Vacuum/Low Flow DT7315 TENS 7000 Elite Rechargeable TENS Unit DT7310 TENS 7000 Sport Massage +EMS (ASIN B0DWKLNDJ6) DT7309 TENS 7000 Massage + EMS (ASIN B0DWKL6T6Z) DT7314 TENS 7000 Massage (ASIN B0DWKMKTXD) Adaptive Cutlery Pedal Exerciser

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2016-05-18
LIH Interferential Current Therapy Neurology Class 2 882.5890 2021-09-16
GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief Neurology Class 2 882.5890 2021-09-16
IPF Stimulator, Muscle, Powered Physical Medicine Class 2 890.5850 2021-09-16
ILH Splint, Hand, And Components Physical Medicine Class 1 890.3475 2016-12-21
INB Attachment, Commode, Wheelchair Physical Medicine Class 1 890.3920 2016-05-18
FSA Lift, Patient, Non-Ac-Powered General Hospital Class 1 880.5510 2016-12-21
LIH Interferential Current Therapy Neurology Class 2 882.5890 2016-09-16
BYX Tubing, Pressure And Accessories Anesthesiology Class 1 868.5860 2016-05-18
BZN Cart, Emergency, Cardiopulmonary (Excluding Equipment) Anesthesiology Class 1 868.6175 2016-05-18
IRT Pad, Heating, Powered Physical Medicine Class 2 890.5740 2016-05-18
NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter Neurology Class 2 882.5890 2024-09-06
FOX Stand, Infusion General Hospital Class 1 880.6990 2016-05-18
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2016-12-21
NFB Conserver, Oxygen Anesthesiology Class 2 868.5905 2016-09-16
CAN Regulator, Pressure, Gas Cylinder Anesthesiology Class 1 868.2700 2016-05-18
GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief Neurology Class 2 882.5890 2016-05-18
ILZ Accessories, Traction Physical Medicine Class 1 890.5925 2011-01-06
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2016-05-18
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2016-05-18
ITS Joint, Hip, External Brace Physical Medicine Class 1 890.3475 2016-05-18
KYX Dispenser, Liquid Medication General Hospital Class 1 880.6430 2016-12-20
IOR Wheelchair, Mechanical Physical Medicine Class 1 890.3850 2016-05-18
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2023-06-09
PGJ Oximeter, Wellness Cardiovascular Class 2 870.2700 2024-06-12
LIH Interferential Current Therapy Neurology Class 2 882.5890 2021-09-16
GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief Neurology Class 2 882.5890 2021-09-16
IPF Stimulator, Muscle, Powered Physical Medicine Class 2 890.5850 2021-09-16
IOR Wheelchair, Mechanical Physical Medicine Class 1 890.3850 2016-05-18
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2016-05-18
GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief Neurology Class 2 882.5890 2018-07-02
IPF Stimulator, Muscle, Powered Physical Medicine Class 2 890.5850 2018-07-02
LIH Interferential Current Therapy Neurology Class 2 882.5890 2018-07-02
PCM Portable Liquid Oxygen Unit Stand Physical Medicine Class 1 890.5050 2021-07-29
FMW Cover, Mattress (Medical Purposes) General Hospital Class 1 880.6190 2016-05-18
CAW Generator, Oxygen, Portable Anesthesiology Class 2 868.5440 2024-08-23
LHD Device, Fertility Diagnostic, Proceptive Unknown Class U N/A 2016-08-05
ISA Massager, Therapeutic, Electric Physical Medicine Class 1 890.5660 2016-05-18
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2016-12-21
LIH Interferential Current Therapy Neurology Class 2 882.5890 2021-09-16
IPF Stimulator, Muscle, Powered Physical Medicine Class 2 890.5850 2021-09-16
GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief Neurology Class 2 882.5890 2021-09-16
IPF Stimulator, Muscle, Powered Physical Medicine Class 2 890.5850 2016-09-16
BXJ Clip, Nose Anesthesiology Class 1 868.6225 2019-10-30
ILS Adaptor, Hygiene Physical Medicine Class 1 890.5050 2016-05-18
FOB Bedpan General Hospital Class 1 880.6730 2019-10-25
IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat Physical Medicine Class 2 890.5860 2022-06-16
GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief Neurology Class 2 882.5890 2022-06-16
IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat Physical Medicine Class 2 890.5300 2022-06-16
LIH Interferential Current Therapy Neurology Class 2 882.5890 2022-06-16
IPF Stimulator, Muscle, Powered Physical Medicine Class 2 890.5850 2022-06-16
ILT Adaptor, Recreational Physical Medicine Class 1 890.5050 2021-03-08
IMP Cushion, Wheelchair Physical Medicine Class 1 890.3920 2010-02-23
INM Chair, With Casters Physical Medicine Class 1 890.3100 2016-05-18
IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat Physical Medicine Class 2 890.5860 2016-05-18
LIH Interferential Current Therapy Neurology Class 2 882.5890 2016-05-18
GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief Neurology Class 2 882.5890 2016-05-18
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2016-05-18
BTK Strap, Head, Gas Mask Anesthesiology Class 1 868.5560 2016-05-19
CBH Device, Fixation, Tracheal Tube Anesthesiology Class 1 868.5770 2016-05-18
KYZ Syringe, Irrigating (Non Dental) General Hospital Class 1 880.6960 2016-12-20
KHY Cane, Safety Walk Physical Medicine Class 1 890.3075 2016-05-18
LIH Interferential Current Therapy Neurology Class 2 882.5890 2016-05-18
GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief Neurology Class 2 882.5890 2016-05-18
IPF Stimulator, Muscle, Powered Physical Medicine Class 2 890.5850 2016-05-18
IQK Orthosis, Cervical Physical Medicine Class 1 890.3490 2016-05-18
IOR Wheelchair, Mechanical Physical Medicine Class 1 890.3850 2016-12-21
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2019-10-30
HST Apparatus, Traction, Non-Powered Orthopedic Class 1 888.5850 2016-05-18
IOR Wheelchair, Mechanical Physical Medicine Class 1 890.3850 2016-05-18
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2023-06-09
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2024-12-20
GYB Media, Electroconductive Neurology Class 2 882.1275 2024-12-20
IOR Wheelchair, Mechanical Physical Medicine Class 1 890.3850 2018-06-25
FNM Mattress, Air Flotation, Alternating Pressure General Hospital Class 2 880.5550 2016-05-18
CAW Generator, Oxygen, Portable Anesthesiology Class 2 868.5440 2026-01-07
NGX Stimulator, Muscle, Powered, For Muscle Conditioning Physical Medicine Class 2 890.5850 2023-06-16
NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter Neurology Class 2 882.5890 2023-06-16
NYN Stimulator, Electrical, Transcutaneous, For Arthritis Neurology Class 2 882.5890 2023-06-16
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2016-09-16
BZA Connector, Airway (Extension) Anesthesiology Class 1 868.5810 2020-06-25
KYW Container, Liquid Medication, Graduated General Hospital Class 1 880.6430 2015-03-24
IPF Stimulator, Muscle, Powered Physical Medicine Class 2 890.5850 2023-11-28
KPI Stimulator, Electrical, Non-Implantable, For Incontinence Gastroenterology, Urology Class 2 876.5320 2023-11-28
GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief Neurology Class 2 882.5890 2023-11-28
HCC Device, Biofeedback Neurology Class 2 882.5050 2023-11-28
ITW Joint, Ankle, External Brace Physical Medicine Class 1 890.3475 2016-05-18
IQI Orthosis, Limb Brace Physical Medicine Class 1 890.3475 2016-12-19
IOR Wheelchair, Mechanical Physical Medicine Class 1 890.3850 2016-12-21
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2020-08-19
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2023-06-09
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2016-08-05
LRX Case, Contact Lens Ophthalmic Class 2 886.5928 2016-09-02
OHY Pill Crusher/Cutter General Hospital Class 1 880.6430 2010-02-23
IPF Stimulator, Muscle, Powered Physical Medicine Class 2 890.5850 2021-09-16
IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat Physical Medicine Class 2 890.5860 2021-09-16
LIH Interferential Current Therapy Neurology Class 2 882.5890 2021-09-16
GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief Neurology Class 2 882.5890 2021-09-16
IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat Physical Medicine Class 2 890.5300 2021-09-16
IOR Wheelchair, Mechanical Physical Medicine Class 1 890.3850 2018-06-25
NFB Conserver, Oxygen Anesthesiology Class 2 868.5905 2019-08-16
CAH Filter, Bacterial, Breathing-Circuit Anesthesiology Class 2 868.5260 2016-09-16
LRX Case, Contact Lens Ophthalmic Class 2 886.5928 2016-09-02
JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered General, Plastic Surgery Class 2 878.4780 2024-10-24
OSI Bariatric Bed General Hospital Class 2 880.5100 2019-01-15
IRP Massager, Powered Inflatable Tube Physical Medicine Class 2 890.5650 2023-03-20
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2016-05-18
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2019-01-23
IME Pack, Hot Or Cold, Reusable Physical Medicine Class 1 890.5700 2008-11-12
NGX Stimulator, Muscle, Powered, For Muscle Conditioning Physical Medicine Class 2 890.5850 2023-06-16
KCM Dropper, Ent Ear, Nose, Throat Class 1 874.5220 2010-04-19
JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered General, Plastic Surgery Class 2 878.4780 2016-05-18
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2018-08-02
GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief Neurology Class 2 882.5890 2016-05-18
IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat Physical Medicine Class 2 890.5860 2016-05-18
IQG Adaptor, Holder, Syringe Physical Medicine Class 1 890.5050 2019-10-30
FNL Bed, Ac-Powered Adjustable Hospital General Hospital Class 2 880.5100 2016-05-18
JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered General, Plastic Surgery Class 2 878.4780 2024-10-24
INP Tips And Pads, Cane, Crutch And Walker Physical Medicine Class 1 890.3790 2010-02-23
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2018-08-02
PCC Stimulator, Nerve, Electrical, Transcutaneous, For Migraine Neurology Class 2 882.5891 2024-10-24
LRX Case, Contact Lens Ophthalmic Class 2 886.5928 2016-09-02
ILY Lamp, Infrared, Therapeutic Heating Physical Medicine Class 2 890.5500 2023-06-16
MUI Media, Coupling, Ultrasound Radiology Class 2 892.1570 2022-06-16
IMD Pack, Hot Or Cold, Disposable Physical Medicine Class 1 890.5710 2010-02-23
NXB Dispenser, Solid Medication Physical Medicine Class 1 890.5050 2015-03-24
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2016-05-18
CAT Cannula, Nasal, Oxygen Anesthesiology Class 1 868.5340 2016-05-18
IRQ Unit, Heating, Powered Physical Medicine Class 1 890.5950 2021-09-16
GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief Neurology Class 2 882.5890 2016-05-18
JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered General, Plastic Surgery Class 2 878.4780 2021-01-11
NFB Conserver, Oxygen Anesthesiology Class 2 868.5905 2016-09-16
IOR Wheelchair, Mechanical Physical Medicine Class 1 890.3850 2017-01-11
CAW Generator, Oxygen, Portable Anesthesiology Class 2 868.5440 2024-11-13
IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat Physical Medicine Class 2 890.5300 2024-02-20
IQE Orthosis, Lumbar Physical Medicine Class 1 890.3490 2016-05-18
KNO Accessories, Wheelchair Physical Medicine Class 1 890.3910 2016-05-18
BZO Set, Tubing And Support, Ventilator (W Harness) Anesthesiology Class 1 868.5975 2016-05-18
IOY Support, Arm Physical Medicine Class 1 890.3475 2016-05-18
JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered General, Plastic Surgery Class 2 878.4780 2016-05-18
IPF Stimulator, Muscle, Powered Physical Medicine Class 2 890.5850 2016-05-18
HGX Pump, Breast, Powered Obstetrics/Gynecology Class 2 884.5160 2016-05-18
KTC Bath, Sitz, Nonpowered Physical Medicine Class 1 890.5125 2010-02-23
NGX Stimulator, Muscle, Powered, For Muscle Conditioning Physical Medicine Class 2 890.5850 2016-05-18
NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter Neurology Class 2 882.5890 2016-05-18
GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered General, Plastic Surgery Class 1 878.4680 2023-07-10
ILC Utensil, Eating Physical Medicine Class 1 890.5050 2016-12-20
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2016-05-18
FMP Protector, Skin Pressure General Hospital Class 1 880.6450 2016-05-18
IMJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat Physical Medicine Class 2 890.5290 2023-06-16
BTI Compressor, Air, Portable Anesthesiology Class 2 868.6250 2016-05-18
IPS Cane Physical Medicine Class 1 890.3075 2010-02-23
ILY Lamp, Infrared, Therapeutic Heating Physical Medicine Class 2 890.5500 2025-05-19
KIA Cover, Cast General Hospital Class 1 880.6185 2010-02-23
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2016-05-18
BTI Compressor, Air, Portable Anesthesiology Class 2 868.6250 2016-05-18
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2017-04-27
IOR Wheelchair, Mechanical Physical Medicine Class 1 890.3850 2018-06-25
ION Exerciser, Non-Measuring Physical Medicine Class 1 890.5370 2022-04-01
IPF Stimulator, Muscle, Powered Physical Medicine Class 2 890.5850 2016-05-18
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2016-08-05

Official Correspondent

Elizabeth Proctor

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Compass Health Brands (Corporate Office)
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3005182235 COMPASS HEALTH BRANDS (DISTRIBUTION CENTER) Brook Park, OH, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K070612 Top-Rank Health Care Equipment Co., Ltd. TOP-RANK ADHESIVE ELECTRODE 2007-05-07
K123915 Grass Technologies, an Astro-Med, Inc. Product Gro DE48-PLUS 2013-04-24
K073532 Technomed Europe DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES 2008-05-01
K260363 Ceribell, Inc. Ceribell Brain Monitor Headband 2026-04-03
K091762 Covidien DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE 2009-12-22

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered
Z-0014-2018 Handicare AB Maskinvagen 1
Carina Mobile Lifts, Models: a) Carina350EM, REF 6060011 b) Carina350EML, REF 60600012 c) Carina350EE, REF 60600009
Z-0037-2010 Airgas Puritan Medical Puritan Medical Unit 1
AGI-2237 Portable 2 Cylinder Manifold Cart, for connecting medical gas cylinders.
Z-0038-2010 Airgas Puritan Medical Puritan Medical Unit 1
AGI-2238 Portable 4 Cylinder Manifold Cart, for connecting medical gas cylinders.
Z-0009-2020 TELEFLEX-MORRISVILLE 2
Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012316249. Last updated year: 2026. Please use registration number 3012316249 when referencing this establishment in official correspondence.
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