BEUDAMED
    FDA Registration Active 🇺🇸 United States

    COMPASS HEALTH BRANDS (CORPORATE OFFICE)

    Reg #: 3012316249 · FEI: 3012316249 · Expires 2026
    View on FDA
    Products
    119
    Proprietary Names
    26
    Establishment Types
    2
    Classifications
    119

    Registration Details

    Registration Name
    COMPASS HEALTH BRANDS (CORPORATE OFFICE)
    Registration Number
    3012316249
    FEI Number
    3012316249
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    6753 Engle Rd
    City
    Middleburg Heights
    State
    OH
    ZIP
    44130
    Country
    US

    Regulatory Submissions

    510(k) Number
    K113375

    Owner / Operator

    Firm Name
    Compass Health Brands (Corporate Office)
    Operator Number
    2182780
    Address
    6753 Engle Rd
    City
    Middleburg Heights
    State
    OH
    Postal Code
    44130
    Country
    US
    Correspondent
    Elizabeth Proctor

    Products

    Device Name Product Code
    Electrode, Cutaneous GXY
    Interferential Current Therapy LIH
    Stimulator, Nerve, Transcutaneous, For Pain Relief GZJ
    Stimulator, Muscle, Powered IPF
    Splint, Hand, And Components ILH
    Attachment, Commode, Wheelchair INB
    Lift, Patient, Non-Ac-Powered FSA
    Tubing, Pressure And Accessories BYX
    Cart, Emergency, Cardiopulmonary (Excluding Equipment) BZN
    Pad, Heating, Powered IRT
    Stimulator, Nerve, Transcutaneous, Over-The-Counter NUH
    Stand, Infusion FOX
    Nebulizer (Direct Patient Interface) CAF
    Conserver, Oxygen NFB
    Regulator, Pressure, Gas Cylinder CAN
    Accessories, Traction ILZ
    Humidifier, Respiratory Gas, (Direct Patient Interface) BTT
    Ventilator, Non-Continuous (Respirator) BZD
    Joint, Hip, External Brace ITS
    Dispenser, Liquid Medication KYX
    Wheelchair, Mechanical IOR
    Oximeter, Wellness PGJ
    Portable Liquid Oxygen Unit Stand PCM
    Cover, Mattress (Medical Purposes) FMW
    Generator, Oxygen, Portable CAW
    Device, Fertility Diagnostic, Proceptive LHD
    Massager, Therapeutic, Electric ISA
    Clip, Nose BXJ
    Adaptor, Hygiene ILS
    Bedpan FOB
    Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat IMG
    Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat IMI
    Adaptor, Recreational ILT
    Cushion, Wheelchair IMP
    Chair, With Casters INM
    Strap, Head, Gas Mask BTK
    Device, Fixation, Tracheal Tube CBH
    Syringe, Irrigating (Non Dental) KYZ
    Cane, Safety Walk KHY
    Orthosis, Cervical IQK
    Continuous Measurement Thermometer FLL
    Apparatus, Traction, Non-Powered HST
    Media, Electroconductive GYB
    Mattress, Air Flotation, Alternating Pressure FNM
    Stimulator, Muscle, Powered, For Muscle Conditioning NGX
    Stimulator, Electrical, Transcutaneous, For Arthritis NYN
    Transducer, Ultrasonic, Diagnostic ITX
    Connector, Airway (Extension) BZA
    Container, Liquid Medication, Graduated KYW
    Stimulator, Electrical, Non-Implantable, For Incontinence KPI
    Device, Biofeedback HCC
    Joint, Ankle, External Brace ITW
    Orthosis, Limb Brace IQI
    Case, Contact Lens LRX
    Pill Crusher/Cutter OHY
    Filter, Bacterial, Breathing-Circuit CAH
    Apparatus, Suction, Ward Use, Portable, Ac-Powered JCX
    Bariatric Bed OSI
    Massager, Powered Inflatable Tube IRP
    Pack, Hot Or Cold, Reusable IME
    Dropper, Ent KCM
    Adaptor, Holder, Syringe IQG
    Bed, Ac-Powered Adjustable Hospital FNL
    Tips And Pads, Cane, Crutch And Walker INP
    Stimulator, Nerve, Electrical, Transcutaneous, For Migraine PCC
    Lamp, Infrared, Therapeutic Heating ILY
    Media, Coupling, Ultrasound MUI
    Pack, Hot Or Cold, Disposable IMD
    Dispenser, Solid Medication NXB
    Cannula, Nasal, Oxygen CAT
    Unit, Heating, Powered IRQ
    Orthosis, Lumbar IQE
    Accessories, Wheelchair KNO
    Set, Tubing And Support, Ventilator (W Harness) BZO
    Support, Arm IOY
    Pump, Breast, Powered HGX
    Bath, Sitz, Nonpowered KTC
    Apparatus, Suction, Single Patient Use, Portable, Nonpowered GCY
    Utensil, Eating ILC
    Protector, Skin Pressure FMP
    Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat IMJ
    Compressor, Air, Portable BTI
    Cane IPS
    Cover, Cast KIA
    Tape And Bandage, Adhesive KGX
    Exerciser, Non-Measuring ION
    Crutch IPR
    Cable, Electrode IKD
    Cushion, Flotation KIC
    Table, Mechanical INW
    Mattress And Bed Deck Cover (Medical Purposes) QTV
    Urinal FNP
    Nebulizer, Medicinal, Non-Ventilatory (Atomizer) CCQ
    Orthosis, Truncal/Orthosis, Limb MRI
    Adaptor, Dressing ILD
    Bottle, Collection, Vacuum KDQ
    Stimulator, Neuromuscular, External Functional GZI
    Device, Iontophoresis, Other Uses EGJ
    Footrest, Wheelchair IMM
    Aid, Transfer IKX
    Components, Wheelchair KNN
    Monitor, Bed Patient KMI
    Chair And Table, Medical KMN
    Bed, Manual FNJ
    Bottle, Hot/Cold Water FPF
    Mask, Oxygen BYG
    Strip, Temperature, Forehead, Liquid Crystal KPD
    Mattress, Flotation Therapy, Non-Powered IKY
    Drain, Tee (Water Trap) BYH
    Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY
    Cushion, Hemorrhoid LRL
    Protector, Hearing (Insert) EWD
    Adult Portable Bed Rails For Medical Purposes QTC
    Walker, Mechanical ITJ
    Oximeter, Infrared, Sporting, Aviation OCH
    Joint, Knee, External Brace ITQ
    Chair, Adjustable, Mechanical INN
    Pack, Heat, Moist IMA
    Exerciser, Powered BXB

    Proprietary Names

    Richmar Cylinder Stand ROSCOE MEDICAL T7 Massager COMPASS HEALTH BRANDS Aid(s) for Daily Living Meridian XMAS TREE O2 ADPTR Apex Compass Health Brands Carex Health Brands DT7308 TENS 7000 Migraine Pain Relief pack, hot or cold, disposable Apex Pill Organizers 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 Meridian Medical Carex TENS 7000 Ear Plugs WC11616DS, WC11816DS, WC12016DS

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility