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[A1]
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Electronic Code of Federal Regulations
| e-CFR data is current as of December 12, 2019
TITLE 21—Food and Drugs
CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) 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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| 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. |
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| Powered lower extremity exoskeleton. |
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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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| Internal therapeutic massager. |
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| Hot or cold disposable pack. |
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| Water circulating hot or cold pack. |
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| Nonpowered lower extremity pressure wrap. |
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| Pressure-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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