FDA medical devices classification list

TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H - MEDICAL DEVICES

    - Scope.
    - Effective dates of requirement for premarket approval.
    - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    - Electrode cable.
    - Chronaximeter.
    - Diagnostic electromyograph.
    - Diagnostic electromyograph needle electrode.
    - Powered reflex hammer.
    - Force-measuring platform.
    - Intermittent pressure measurement system.
    - Miniature pressure transducer.
    - Diagnostic muscle stimulator.
    - Isokinetic testing and evaluation system.

Subpart C [Reserved]

    - Prosthetic and orthotic accessory.
    - Cane.
    - Mechanical chair.
    - Electric positioning chair.
    - Crutch.
    - Flotation cushion.
    - External limb orthotic component.
    - External limb prosthetic component.
    - Upper extremity prosthesis including a simultaneously powered elbow and/or shoulder with greater than two simultaneous powered degrees of freedom and controlled by non-implanted electrical components.
    - Limb orthosis.
    - Powered lower extremity exoskeleton.
    - Truncal orthosis.
    - External assembled lower limb prosthesis.
    - Plinth.
    - Rigid pneumatic structure orthosis.
    - Arm sling.
    - Congenital hip dislocation abduction splint.
    - Denis Brown splint.
    - Powered wheeled stretcher.
    - Nonpowered communication system.

  - Powered communication system.
    - Powered environmental control system.
    - Mechanical table.
    - Powered table.
    - Cane, crutch, and walker tips and pads.
    - Motorized three-wheeled vehicle.
    - Mechanical walker.
    - Mechanical wheelchair.
    - Powered wheelchair.
    - Special grade wheelchair.
    - Stair-climbing wheelchair.
    - Standup wheelchair.
    - Wheelchair accessory.
    - Wheelchair component.
    - Wheelchair elevator.
    - Wheelchair platform scale.

Subpart E [Reserved]

    - Daily activity assist device.
    - Immersion hydrobath.
    - Paraffin bath.
    - Nonpowered sitz bath.
    - Powered patient transport.
    - Air-fluidized bed.
    - Powered flotation therapy bed.
    - Manual patient rotation bed.
    - Powered patient rotation bed.
    - Moist steam cabinet.
    - Microwave diathermy.
    - Shortwave diathermy.
    - Ultrasonic diathermy.
    - Exercise component.
    - Measuring exercise equipment.
    - Nonmeasuring exercise equipment.
    - Powered exercise equipment.
    - Powered finger exerciser.
    - Infrared lamp.
    - Iontophoresis device.
    - Powered external limb overload warning device.
    - Powered inflatable tube massager.
    - Therapeutic massager.
    - Internal therapeutic massager.
    - Cold pack.
  - Hot or cold disposable pack.
    - Water circulating hot or cold pack.
    - Moist heat pack.
    - Powered heating pad.
    - Nonpowered lower extremity pressure wrap.
    - Pressure-applying device.
    - Powered muscle stimulator.
    - Ultrasound and muscle stimulator.
    - Multi-function physical therapy table.
    - Power traction equipment.
    - Traction accessory.
    - Chilling unit.
    - Powered heating unit.
    - Therapeutic vibrator.

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
Source: 48 FR 53047, Nov. 23, 1983, unless otherwise noted.

Extracted from US.FDA