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- 21 CFR 888.4505 · Orthopedic surgical instrumentation designed for osteochondral implants with press-fit fixation.
- 21 CFR 888.4510 · Manual surgical instrument for appropriate patient selection for orthopedic implant.
- 21 CFR 888.4515 · Orthopedic manual surgical instrumentation for use with total disc replacement devices.
- 21 CFR 888.4520 · Orthopedic manual surgical instrumentation for use with non-fusion spinous process spacer devices.
- 21 CFR 888.4540 · Orthopedic manual surgical instrument.
- 21 CFR 888.4560 · Intraoperative surgical angle measurement tool.
- 21 CFR 888.4580 · Sonic surgical instrument and accessories/attachments.
- 21 CFR 888.4600 · Protractor for clinical use.
- 21 CFR 888.4800 · Template for clinical use.
- 21 CFR 888.5850 · Nonpowered orthopedic traction apparatus and accessories.
- 21 CFR 888.5890 · Noninvasive traction component.
- 21 CFR 888.5940 · Cast component.
- 21 CFR 888.5960 · Cast removal instrument.
- 21 CFR 888.5980 · Manual cast application and removal instrument.
- 21 CFR 890.1 · Scope.
- 21 CFR 890.3 · Effective dates of requirement for premarket approval.
- 21 CFR 890.9 · Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
- 21 CFR 890.1175 · Electrode cable.
- 21 CFR 890.1225 · Chronaximeter.
- 21 CFR 890.1375 · Diagnostic electromyograph.
- 21 CFR 890.1385 · Diagnostic electromyograph needle electrode.
- 21 CFR 890.1450 · Powered reflex hammer.
- 21 CFR 890.1575 · Force-measuring platform.
- 21 CFR 890.1600 · Intermittent pressure measurement system.
- 21 CFR 890.1615 · Miniature pressure transducer.
- 21 CFR 890.1850 · Diagnostic muscle stimulator.
- 21 CFR 890.1925 · Isokinetic testing and evaluation system.
- 21 CFR 890.3025 · Prosthetic and orthotic accessory.
- 21 CFR 890.3050 · External compression device for internal jugular vein compression.
- 21 CFR 890.3075 · Cane.
- 21 CFR 890.3100 · Mechanical chair.
- 21 CFR 890.3110 · Electric positioning chair.
- 21 CFR 890.3150 · Crutch.
- 21 CFR 890.3175 · Flotation cushion.
- 21 CFR 890.3410 · External limb orthotic component.
- 21 CFR 890.3420 · External limb prosthetic component.
- 21 CFR 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 CFR 890.3475 · Limb orthosis.
- 21 CFR 890.3480 · Powered lower extremity exoskeleton.
- 21 CFR 890.3490 · Truncal orthosis.
- 21 CFR 890.3500 · External assembled lower limb prosthesis.
- 21 CFR 890.3520 · Plinth.
- 21 CFR 890.3610 · Rigid pneumatic structure orthosis.
- 21 CFR 890.3640 · Arm sling.
- 21 CFR 890.3665 · Congenital hip dislocation abduction splint.
- 21 CFR 890.3675 · Denis Brown splint.
- 21 CFR 890.3690 · Powered wheeled stretcher.
- 21 CFR 890.3700 · Nonpowered communication system.
- 21 CFR 890.3710 · Powered communication system.
- 21 CFR 890.3725 · Powered environmental control system.
- 21 CFR 890.3750 · Mechanical table.
- 21 CFR 890.3760 · Powered table.
- 21 CFR 890.3790 · Cane, crutch, and walker tips and pads.
- 21 CFR 890.3800 · Motorized three-wheeled vehicle.
- 21 CFR 890.3825 · Mechanical walker.
- 21 CFR 890.3850 · Mechanical wheelchair.
- 21 CFR 890.3860 · Powered wheelchair.
- 21 CFR 890.3880 · Special grade wheelchair.
- 21 CFR 890.3890 · Stair-climbing wheelchair.
- 21 CFR 890.3900 · Standup wheelchair.
- 21 CFR 890.3910 · Wheelchair accessory.
- 21 CFR 890.3920 · Wheelchair component.
- 21 CFR 890.3930 · Wheelchair elevator.
- 21 CFR 890.3940 · Wheelchair platform scale.
- 21 CFR 890.5050 · Daily activity assist device.
- 21 CFR 890.5100 · Immersion hydrobath.
- 21 CFR 890.5110 · Paraffin bath.
- 21 CFR 890.5125 · Nonpowered sitz bath.
- 21 CFR 890.5150 · Powered patient transport.
- 21 CFR 890.5160 · Air-fluidized bed.
- 21 CFR 890.5170 · Powered flotation therapy bed.
- 21 CFR 890.5180 · Manual patient rotation bed.
- 21 CFR 890.5225 · Powered patient rotation bed.
- 21 CFR 890.5250 · Moist steam cabinet.
- 21 CFR 890.5275 · Microwave diathermy.
- 21 CFR 890.5290 · Shortwave diathermy.
- 21 CFR 890.5300 · Ultrasonic diathermy.
- 21 CFR 890.5350 · Exercise component.
- 21 CFR 890.5360 · Measuring exercise equipment.
- 21 CFR 890.5370 · Nonmeasuring exercise equipment.
- 21 CFR 890.5380 · Powered exercise equipment.
- 21 CFR 890.5410 · Powered finger exerciser.
- 21 CFR 890.5420 · Electroencephalography (EEG)-driven upper extremity powered exerciser.
- 21 CFR 890.5500 · Infrared lamp.
- 21 CFR 890.5525 · Iontophoresis device.
- 21 CFR 890.5575 · Powered external limb overload warning device.
- 21 CFR 890.5650 · Powered inflatable tube massager.
- 21 CFR 890.5660 · Therapeutic massager.
- 21 CFR 890.5670 · Internal therapeutic massager.
- 21 CFR 890.5700 · Cold pack.
- 21 CFR 890.5710 · Hot or cold disposable pack.
- 21 CFR 890.5720 · Water circulating hot or cold pack.
- 21 CFR 890.5730 · Moist heat pack.
- 21 CFR 890.5740 · Powered heating pad.
- 21 CFR 890.5760 · Nonpowered lower extremity pressure wrap.
- 21 CFR 890.5765 · Pressure-applying device.
- 21 CFR 890.5800 · Virtual reality behavioral therapy device for pain relief.
- 21 CFR 890.5850 · Powered muscle stimulator.
- 21 CFR 890.5860 · Ultrasound and muscle stimulator.
- 21 CFR 890.5870 · Non-invasive bone growth stimulator.