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