Title 21

PART 890

Part 890 - Physical Medicine Devices

PART 890 - PHYSICAL MEDICINE DEVICES Authority:21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. Source:48 FR 53047, Nov. 23, 1983, unless otherwise noted. Editorial Note:Nomenclature changes to part 890 appear at 73 FR 35341, June 23, 2008.

21:8.0.1.1.32.1SUBPART A
Subpart A - General Provisions
21:8.0.1.1.32.1.1.1SECTION 890.1
   890.1 Scope.
21:8.0.1.1.32.1.1.2SECTION 890.3
   890.3 Effective dates of requirement for premarket approval.
21:8.0.1.1.32.1.1.3SECTION 890.9
   890.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
21:8.0.1.1.32.2SUBPART B
Subpart B - Physical Medicine Diagnostic Devices
21:8.0.1.1.32.2.1.1SECTION 890.1175
   890.1175 Electrode cable.
21:8.0.1.1.32.2.1.2SECTION 890.1225
   890.1225 Chronaximeter.
21:8.0.1.1.32.2.1.3SECTION 890.1375
   890.1375 Diagnostic electromyograph.
21:8.0.1.1.32.2.1.4SECTION 890.1385
   890.1385 Diagnostic electromyograph needle electrode.
21:8.0.1.1.32.2.1.5SECTION 890.1450
   890.1450 Powered reflex hammer.
21:8.0.1.1.32.2.1.6SECTION 890.1575
   890.1575 Force-measuring platform.
21:8.0.1.1.32.2.1.7SECTION 890.1600
   890.1600 Intermittent pressure measurement system.
21:8.0.1.1.32.2.1.8SECTION 890.1615
   890.1615 Miniature pressure transducer.
21:8.0.1.1.32.2.1.9SECTION 890.1850
   890.1850 Diagnostic muscle stimulator.
21:8.0.1.1.32.2.1.10SECTION 890.1925
   890.1925 Isokinetic testing and evaluation system.
21:8.0.1.1.32.3SUBPART C
Subpart C [Reserved]
21:8.0.1.1.32.4SUBPART D
Subpart D - Physical Medicine Prosthetic Devices
21:8.0.1.1.32.4.1.1SECTION 890.3025
   890.3025 Prosthetic and orthotic accessory.
21:8.0.1.1.32.4.1.2SECTION 890.3075
   890.3075 Cane.
21:8.0.1.1.32.4.1.3SECTION 890.3100
   890.3100 Mechanical chair.
21:8.0.1.1.32.4.1.4SECTION 890.3110
   890.3110 Electric positioning chair.
21:8.0.1.1.32.4.1.5SECTION 890.3150
   890.3150 Crutch.
21:8.0.1.1.32.4.1.6SECTION 890.3175
   890.3175 Flotation cushion.
21:8.0.1.1.32.4.1.7SECTION 890.3410
   890.3410 External limb orthotic component.
21:8.0.1.1.32.4.1.8SECTION 890.3420
   890.3420 External limb prosthetic component.
21:8.0.1.1.32.4.1.9SECTION 890.3450
   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.
21:8.0.1.1.32.4.1.10SECTION 890.3475
   890.3475 Limb orthosis.
21:8.0.1.1.32.4.1.11SECTION 890.3480
   890.3480 Powered lower extremity exoskeleton.
21:8.0.1.1.32.4.1.12SECTION 890.3490
   890.3490 Truncal orthosis.
21:8.0.1.1.32.4.1.13SECTION 890.3500
   890.3500 External assembled lower limb prosthesis.
21:8.0.1.1.32.4.1.14SECTION 890.3520
   890.3520 Plinth.
21:8.0.1.1.32.4.1.15SECTION 890.3610
   890.3610 Rigid pneumatic structure orthosis.
21:8.0.1.1.32.4.1.16SECTION 890.3640
   890.3640 Arm sling.
21:8.0.1.1.32.4.1.17SECTION 890.3665
   890.3665 Congenital hip dislocation abduction splint.
21:8.0.1.1.32.4.1.18SECTION 890.3675
   890.3675 Denis Brown splint.
21:8.0.1.1.32.4.1.19SECTION 890.3690
   890.3690 Powered wheeled stretcher.
21:8.0.1.1.32.4.1.20SECTION 890.3700
   890.3700 Nonpowered communication system.
21:8.0.1.1.32.4.1.21SECTION 890.3710
   890.3710 Powered communication system.
21:8.0.1.1.32.4.1.22SECTION 890.3725
   890.3725 Powered environmental control system.
21:8.0.1.1.32.4.1.23SECTION 890.3750
   890.3750 Mechanical table.
21:8.0.1.1.32.4.1.24SECTION 890.3760
   890.3760 Powered table.
21:8.0.1.1.32.4.1.25SECTION 890.3790
   890.3790 Cane, crutch, and walker tips and pads.
21:8.0.1.1.32.4.1.26SECTION 890.3800
   890.3800 Motorized three-wheeled vehicle.
21:8.0.1.1.32.4.1.27SECTION 890.3825
   890.3825 Mechanical walker.
21:8.0.1.1.32.4.1.28SECTION 890.3850
   890.3850 Mechanical wheelchair.
21:8.0.1.1.32.4.1.29SECTION 890.3860
   890.3860 Powered wheelchair.
21:8.0.1.1.32.4.1.30SECTION 890.3880
   890.3880 Special grade wheelchair.
21:8.0.1.1.32.4.1.31SECTION 890.3890
   890.3890 Stair-climbing wheelchair.
21:8.0.1.1.32.4.1.32SECTION 890.3900
   890.3900 Standup wheelchair.
21:8.0.1.1.32.4.1.33SECTION 890.3910
   890.3910 Wheelchair accessory.
21:8.0.1.1.32.4.1.34SECTION 890.3920
   890.3920 Wheelchair component.
21:8.0.1.1.32.4.1.35SECTION 890.3930
   890.3930 Wheelchair elevator.
21:8.0.1.1.32.4.1.36SECTION 890.3940
   890.3940 Wheelchair platform scale.
21:8.0.1.1.32.5SUBPART E
Subpart E [Reserved]
21:8.0.1.1.32.6SUBPART F
Subpart F - Physical Medicine Therapeutic Devices
21:8.0.1.1.32.6.1.1SECTION 890.5050
   890.5050 Daily activity assist device.
21:8.0.1.1.32.6.1.2SECTION 890.5100
   890.5100 Immersion hydrobath.
21:8.0.1.1.32.6.1.3SECTION 890.5110
   890.5110 Paraffin bath.
21:8.0.1.1.32.6.1.4SECTION 890.5125
   890.5125 Nonpowered sitz bath.
21:8.0.1.1.32.6.1.5SECTION 890.5150
   890.5150 Powered patient transport.
21:8.0.1.1.32.6.1.6SECTION 890.5160
   890.5160 Air-fluidized bed.
21:8.0.1.1.32.6.1.7SECTION 890.5170
   890.5170 Powered flotation therapy bed.
21:8.0.1.1.32.6.1.8SECTION 890.5180
   890.5180 Manual patient rotation bed.
21:8.0.1.1.32.6.1.9SECTION 890.5225
   890.5225 Powered patient rotation bed.
21:8.0.1.1.32.6.1.10SECTION 890.5250
   890.5250 Moist steam cabinet.
21:8.0.1.1.32.6.1.11SECTION 890.5275
   890.5275 Microwave diathermy.
21:8.0.1.1.32.6.1.12SECTION 890.5290
   890.5290 Shortwave diathermy.
21:8.0.1.1.32.6.1.13SECTION 890.5300
   890.5300 Ultrasonic diathermy.
21:8.0.1.1.32.6.1.14SECTION 890.5350
   890.5350 Exercise component.
21:8.0.1.1.32.6.1.15SECTION 890.5360
   890.5360 Measuring exercise equipment.
21:8.0.1.1.32.6.1.16SECTION 890.5370
   890.5370 Nonmeasuring exercise equipment.
21:8.0.1.1.32.6.1.17SECTION 890.5380
   890.5380 Powered exercise equipment.
21:8.0.1.1.32.6.1.18SECTION 890.5410
   890.5410 Powered finger exerciser.
21:8.0.1.1.32.6.1.19SECTION 890.5500
   890.5500 Infrared lamp.
21:8.0.1.1.32.6.1.20SECTION 890.5525
   890.5525 Iontophoresis device.
21:8.0.1.1.32.6.1.21SECTION 890.5575
   890.5575 Powered external limb overload warning device.
21:8.0.1.1.32.6.1.22SECTION 890.5650
   890.5650 Powered inflatable tube massager.
21:8.0.1.1.32.6.1.23SECTION 890.5660
   890.5660 Therapeutic massager.
21:8.0.1.1.32.6.1.24SECTION 890.5670
   890.5670 Internal therapeutic massager.
21:8.0.1.1.32.6.1.25SECTION 890.5700
   890.5700 Cold pack.
21:8.0.1.1.32.6.1.26SECTION 890.5710
   890.5710 Hot or cold disposable pack.
21:8.0.1.1.32.6.1.27SECTION 890.5720
   890.5720 Water circulating hot or cold pack.
21:8.0.1.1.32.6.1.28SECTION 890.5730
   890.5730 Moist heat pack.
21:8.0.1.1.32.6.1.29SECTION 890.5740
   890.5740 Powered heating pad.
21:8.0.1.1.32.6.1.30SECTION 890.5760
   890.5760 Nonpowered lower extremity pressure wrap.
21:8.0.1.1.32.6.1.31SECTION 890.5765
   890.5765 Pressure-applying device.
21:8.0.1.1.32.6.1.32SECTION 890.5850
   890.5850 Powered muscle stimulator.
21:8.0.1.1.32.6.1.33SECTION 890.5860
   890.5860 Ultrasound and muscle stimulator.
21:8.0.1.1.32.6.1.34SECTION 890.5880
   890.5880 Multi-function physical therapy table.
21:8.0.1.1.32.6.1.35SECTION 890.5900
   890.5900 Power traction equipment.
21:8.0.1.1.32.6.1.36SECTION 890.5925
   890.5925 Traction accessory.
21:8.0.1.1.32.6.1.37SECTION 890.5940
   890.5940 Chilling unit.
21:8.0.1.1.32.6.1.38SECTION 890.5950
   890.5950 Powered heating unit.
21:8.0.1.1.32.6.1.39SECTION 890.5975
   890.5975 Therapeutic vibrator.