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e-CFR data is current as of January 21, 2021

Title 21 → Chapter I → Subchapter H → Part 890

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

rule

Subpart A—GENERAL PROVISIONS

§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).
rule

Subpart B—PHYSICAL MEDICINE DIAGNOSTIC DEVICES

§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.
rule

Subpart C—[RESERVED]

rule

Subpart D—PHYSICAL MEDICINE PROSTHETIC DEVICES

§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.
§890.3450
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.
§890.3475
Limb orthosis.
§890.3480
Powered lower extremity exoskeleton.
§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.
rule

Subpart E—[RESERVED]

rule

Subpart F—PHYSICAL MEDICINE THERAPEUTIC DEVICES

§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.
§890.5670
Internal 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.
§890.5760
Nonpowered lower extremity pressure wrap.
§890.5765
Pressure-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.

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