Home/CFR/Title 21/Part 890
FEDERAL · 21 CFR

Part 890 — Physical Medicine Devices

91 sections · Title 21: Food and Drugs

§ 890.1Scope.
§ 890.3Effective dates of requirement for premarket approval.
§ 890.9Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
§ 890.1175Electrode cable.
§ 890.1225Chronaximeter.
§ 890.1375Diagnostic electromyograph.
§ 890.1385Diagnostic electromyograph needle electrode.
§ 890.1450Powered reflex hammer.
§ 890.1575Force-measuring platform.
§ 890.1600Intermittent pressure measurement system.
§ 890.1615Miniature pressure transducer.
§ 890.1850Diagnostic muscle stimulator.
§ 890.1925Isokinetic testing and evaluation system.
§ 890.3025Prosthetic and orthotic accessory.
§ 890.3050External compression device for internal jugular vein compression.
§ 890.3075Cane.
§ 890.3100Mechanical chair.
§ 890.3110Electric positioning chair.
§ 890.3150Crutch.
§ 890.3175Flotation cushion.
§ 890.3410External limb orthotic component.
§ 890.3420External limb prosthetic component.
§ 890.3450Upper 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.
§ 890.3475Limb orthosis.
§ 890.3480Powered lower extremity exoskeleton.
§ 890.3490Truncal orthosis.
§ 890.3500External assembled lower limb prosthesis.
§ 890.3520Plinth.
§ 890.3610Rigid pneumatic structure orthosis.
§ 890.3640Arm sling.
§ 890.3665Congenital hip dislocation abduction splint.
§ 890.3675Denis Brown splint.
§ 890.3690Powered wheeled stretcher.
§ 890.3700Nonpowered communication system.
§ 890.3710Powered communication system.
§ 890.3725Powered environmental control system.
§ 890.3750Mechanical table.
§ 890.3760Powered table.
§ 890.3790Cane, crutch, and walker tips and pads.
§ 890.3800Motorized three-wheeled vehicle.
§ 890.3825Mechanical walker.
§ 890.3850Mechanical wheelchair.
§ 890.3860Powered wheelchair.
§ 890.3880Special grade wheelchair.
§ 890.3890Stair-climbing wheelchair.
§ 890.3900Standup wheelchair.
§ 890.3910Wheelchair accessory.
§ 890.3920Wheelchair component.
§ 890.3930Wheelchair elevator.
§ 890.3940Wheelchair platform scale.
§ 890.5050Daily activity assist device.
§ 890.5100Immersion hydrobath.
§ 890.5110Paraffin bath.
§ 890.5125Nonpowered sitz bath.
§ 890.5150Powered patient transport.
§ 890.5160Air-fluidized bed.
§ 890.5170Powered flotation therapy bed.
§ 890.5180Manual patient rotation bed.
§ 890.5225Powered patient rotation bed.
§ 890.5250Moist steam cabinet.
§ 890.5275Microwave diathermy.
§ 890.5290Shortwave diathermy.
§ 890.5300Ultrasonic diathermy.
§ 890.5350Exercise component.
§ 890.5360Measuring exercise equipment.
§ 890.5370Nonmeasuring exercise equipment.
§ 890.5380Powered exercise equipment.
§ 890.5410Powered finger exerciser.
§ 890.5420Electroencephalography (EEG)-driven upper extremity powered exerciser.
§ 890.5500Infrared lamp.
§ 890.5525Iontophoresis device.
§ 890.5575Powered external limb overload warning device.
§ 890.5650Powered inflatable tube massager.
§ 890.5660Therapeutic massager.
§ 890.5670Internal therapeutic massager.
§ 890.5700Cold pack.
§ 890.5710Hot or cold disposable pack.
§ 890.5720Water circulating hot or cold pack.
§ 890.5730Moist heat pack.
§ 890.5740Powered heating pad.
§ 890.5760Nonpowered lower extremity pressure wrap.
§ 890.5765Pressure-applying device.
§ 890.5800Virtual reality behavioral therapy device for pain relief.
§ 890.5850Powered muscle stimulator.
§ 890.5860Ultrasound and muscle stimulator.
§ 890.5880Multi-function physical therapy table.
§ 890.5900Power traction equipment.
§ 890.5925Traction accessory.
§ 890.5940Chilling unit.
§ 890.5950Powered heating unit.
§ 890.5975Therapeutic vibrator.