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