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Code of Federal Regulations (Last Updated: May 6, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 890 - Physical Medicine 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 - XXX |
| 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. |
| § 890.3475 - 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 - XXX |
| 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. |
| § 890.5420 - Electroencephalography (EEG)-driven upper extremity powered 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. |
| § 890.5800 - Virtual reality behavioral therapy device for pain relief. |
| § 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. |