Title 21, Part 890 — Physical Medicine 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.

Prosthetic and orthotic accessory.

External compression device for internal jugular vein compression.

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.

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.

Electroencephalography (EEG)-driven upper extremity powered 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.

Virtual reality behavioral therapy device for pain relief.

Powered muscle stimulator.

Ultrasound and muscle stimulator.

Multi-function physical therapy table.

Power traction equipment.

Traction accessory.

Chilling unit.

Powered heating unit.

Therapeutic vibrator.