13530458900

FDA medical devices classification list

TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H - MEDICAL DEVICES

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).

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.

Subpart C [Reserved]

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.

Subpart E [Reserved]

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.

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
Source: 48 FR 53047, Nov. 23, 1983, unless otherwise noted.

Extracted from US.FDA