FDA 21 CFR Part 890 Physical Medicine Devices

Sathyanarayana M.Sc.
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FDA 21 CFR Part 890 Physical Medicine Devices
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Table of contents


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.

890.3075 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.

890.5500 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.

890.5850 Powered muscle stimulator.

890.5860 Ultrasound and muscle 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.



FDA 21 CFR Part 890 Physical Medicine Devices:

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