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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