21 CFR Part 890
PART 890—PHYSICAL MEDICINE DEVICES
- PART 890—PHYSICAL MEDICINE DEVICES
- Chapter I—Food and Drug Administration, Department of Health and Human Services › Subchapter H—Medical Devices
- Subpart A—General Provisions
- § 890.1 Scope.
- § 890.3 Effective dates of requirement for premarket approval.
- § 890.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
- Subpart B—Physical Medicine Diagnostic Devices
- § 890.1175 Electrode cable.
- § 890.1225 Chronaximeter.
- § 890.1375 Diagnostic electromyograph.
- § 890.1385 Diagnostic electromyograph needle electrode.
- § 890.1450 Powered reflex hammer.
- § 890.1575 Force-measuring platform.
- § 890.1600 Intermittent pressure measurement system.
- § 890.1615 Miniature pressure transducer.
- § 890.1850 Diagnostic muscle stimulator.
- § 890.1925 Isokinetic testing and evaluation system.
- Subpart C [Reserved]
- Subpart D—Physical Medicine Prosthetic Devices
- § 890.3025 Prosthetic and orthotic accessory.
- § 890.3050 External compression device for internal jugular vein compression.
- § 890.3075 Cane.
- § 890.3100 Mechanical chair.
- § 890.3110 Electric positioning chair.
- § 890.3150 Crutch.
- § 890.3175 Flotation cushion.
- § 890.3410 External limb orthotic component.
- § 890.3420 External limb prosthetic component.
- § 890.3450 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.
- § 890.3475 Limb orthosis.
- § 890.3480 Powered lower extremity exoskeleton.
- § 890.3490 Truncal orthosis.
- § 890.3500 External assembled lower limb prosthesis.
- § 890.3520 Plinth.
- § 890.3610 Rigid pneumatic structure orthosis.
- § 890.3640 Arm sling.
- § 890.3665 Congenital hip dislocation abduction splint.
- § 890.3675 Denis Brown splint.
- § 890.3690 Powered wheeled stretcher.
- § 890.3700 Nonpowered communication system.
- § 890.3710 Powered communication system.
- § 890.3725 Powered environmental control system.
- § 890.3750 Mechanical table.
- § 890.3760 Powered table.
- § 890.3790 Cane, crutch, and walker tips and pads.
- § 890.3800 Motorized three-wheeled vehicle.
- § 890.3825 Mechanical walker.
- § 890.3850 Mechanical wheelchair.
- § 890.3860 Powered wheelchair.
- § 890.3880 Special grade wheelchair.
- § 890.3890 Stair-climbing wheelchair.
- § 890.3900 Standup wheelchair.
- § 890.3910 Wheelchair accessory.
- § 890.3920 Wheelchair component.
- § 890.3930 Wheelchair elevator.
- § 890.3940 Wheelchair platform scale.
- Subpart E [Reserved]
- Subpart F—Physical Medicine Therapeutic Devices
- § 890.5050 Daily activity assist device.
- § 890.5100 Immersion hydrobath.
- § 890.5110 Paraffin bath.
- § 890.5125 Nonpowered sitz bath.
- § 890.5150 Powered patient transport.
- § 890.5160 Air-fluidized bed.
- § 890.5170 Powered flotation therapy bed.
- § 890.5180 Manual patient rotation bed.
- § 890.5225 Powered patient rotation bed.
- § 890.5250 Moist steam cabinet.
- § 890.5275 Microwave diathermy.
- § 890.5290 Shortwave diathermy.
- § 890.5300 Ultrasonic diathermy.
- § 890.5350 Exercise component.
- § 890.5360 Measuring exercise equipment.
- § 890.5370 Nonmeasuring exercise equipment.
- § 890.5380 Powered exercise equipment.
- § 890.5410 Powered finger exerciser.
- § 890.5420 Electroencephalography (EEG)-driven upper extremity powered exerciser.
- § 890.5500 Infrared lamp.
- § 890.5525 Iontophoresis device.
- § 890.5575 Powered external limb overload warning device.
- § 890.5650 Powered inflatable tube massager.
- § 890.5660 Therapeutic massager.
- § 890.5670 Internal therapeutic massager.
- § 890.5700 Cold pack.
- § 890.5710 Hot or cold disposable pack.
- § 890.5720 Water circulating hot or cold pack.
- § 890.5730 Moist heat pack.
- § 890.5740 Powered heating pad.
- § 890.5760 Nonpowered lower extremity pressure wrap.
- § 890.5765 Pressure-applying device.
- § 890.5800 Virtual reality behavioral therapy device for pain relief.
- § 890.5850 Powered muscle stimulator.
- § 890.5860 Ultrasound and muscle stimulator.
- § 890.5870 Non-invasive bone growth stimulator.
- § 890.5880 Multi-function physical therapy table.
- § 890.5900 Power traction equipment.
- § 890.5925 Traction accessory.
- § 890.5940 Chilling unit.
- § 890.5950 Powered heating unit.
- § 890.5975 Therapeutic vibrator.
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