21 C.F.R. PART 890--PHYSICAL MEDICINE DEVICES
TITLE 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 890--PHYSICAL MEDICINE DEVICES
Subpart A--GENERAL PROVISIONS
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| Effective dates of requirement for premarket approval.
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| Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
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Subpart B--PHYSICAL MEDICINE DIAGNOSTIC DEVICES
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| Diagnostic electromyograph.
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| Diagnostic electromyograph needle electrode.
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| Force-measuring platform.
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| Intermittent pressure measurement system.
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| Miniature pressure transducer.
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| Diagnostic muscle stimulator.
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| Isokinetic testing and evaluation system.
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Subpart C--[RESERVED]
Subpart D--PHYSICAL MEDICINE PROSTHETIC DEVICES
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| Prosthetic and orthotic accessory.
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| Electric positioning chair.
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| External limb orthotic component.
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| External limb prosthetic component.
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| External assembled lower limb prosthesis.
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| Rigid pneumatic structure orthosis.
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| Congenital hip dislocation abduction splint.
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| Powered wheeled stretcher.
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| Nonpowered communication system.
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| Powered communication system.
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| Powered environmental control system.
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| Cane, crutch, and walker tips and pads.
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| Motorized three-wheeled vehicle.
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| Special grade wheelchair.
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| Stair-climbing wheelchair.
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| Wheelchair platform scale.
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Subpart E--[RESERVED]
Subpart F--PHYSICAL MEDICINE THERAPEUTIC DEVICES
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| Daily activity assist device.
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| Powered patient transport.
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| Powered flotation therapy bed.
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| Manual patient rotation bed.
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| Powered patient rotation bed.
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| Measuring exercise equipment.
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| Nonmeasuring exercise equipment.
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| Powered exercise equipment.
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| Powered finger exerciser.
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| Powered external limb overload warning device.
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| Powered inflatable tube massager.
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| Hot or cold disposable pack.
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| Water circulating hot or cold pack.
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| Presssure-applying device.
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| Powered muscle stimulator.
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| Ultrasound and muscle stimulator.
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| Multi-function physical therapy table.
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| Power traction equipment.
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