2001 CFR Title 21, Volume 8

Title 21--Food and Drugs CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued) PART 890--PHYSICAL MEDICINE DEVICES
	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).
	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.
	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.
	890.3475	Limb orthosis.
	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.
	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.
	890.5700	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.
	890.5765	Presssure-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.