Section 890.1
|
Effective dates of requirement for premarket approval |
Section 890.3
|
Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act) |
Section 890.9
|
Electrode cable |
Section 890.1175
|
Chronaximeter |
Section 890.1225
|
Diagnostic electromyograph |
Section 890.1375
|
Diagnostic electromyograph needle electrode |
Section 890.1385
|
Powered reflex hammer |
Section 890.1450
|
Force-measuring platform |
Section 890.1575
|
Intermittent pressure measurement system |
Section 890.1600
|
Miniature pressure transducer |
Section 890.1615
|
Diagnostic muscle stimulator |
Section 890.1850
|
Isokinetic testing and evaluation system |
Section 890.1925
|
Prosthetic and orthotic accessory |
Section 890.3025
|
Cane |
Section 890.3075
|
Mechanical chair |
Section 890.3100
|
Electric positioning chair |
Section 890.3110
|
Crutch |
Section 890.3150
|
Flotation cushion |
Section 890.3175
|
External limb orthotic component |
Section 890.3410
|
External limb prosthetic component |
Section 890.3420
|
Limb orthosis |
Section 890.3475
|
Powered exoskeleton |
Section 890.3480
|
Truncal orthosis |
Section 890.3490
|
External assembled lower limb prosthesis |
Section 890.3500
|
Plinth |
Section 890.3520
|
Rigid pneumatic structure orthosis |
Section 890.3610
|
Arm sling |
Section 890.3640
|
Congenital hip dislocation abduction splint |
Section 890.3665
|
Denis Brown splint |
Section 890.3675
|
Powered wheeled stretcher |
Section 890.3690
|
Nonpowered communication system |
Section 890.3700
|
Powered communication system |
Section 890.3710
|
Powered environmental control system |
Section 890.3725
|
Mechanical table |
Section 890.3750
|
Powered table |
Section 890.3760
|
Cane, crutch, and walker tips and pads |
Section 890.3790
|
Motorized three-wheeled vehicle |
Section 890.3800
|
Mechanical walker |
Section 890.3825
|
Mechanical wheelchair |
Section 890.3850
|
Powered wheelchair |
Section 890.3860
|
Special grade wheelchair |
Section 890.3880
|
Stair-climbing wheelchair |
Section 890.3890
|
Standup wheelchair |
Section 890.3900
|
Wheelchair accessory |
Section 890.3910
|
Wheelchair component |
Section 890.3920
|
Wheelchair elevator |
Section 890.3930
|
Wheelchair platform scale |
Section 890.3940
|
Daily activity assist device |
Section 890.5050
|
Immersion hydrobath |
Section 890.5100
|
Paraffin bath |
Section 890.5110
|
Nonpowered sitz bath |
Section 890.5125
|
Powered patient transport |
Section 890.5150
|
Air-fluidized bed |
Section 890.5160
|
Powered flotation therapy bed |
Section 890.5170
|
Manual patient rotation bed |
Section 890.5180
|
Powered patient rotation bed |
Section 890.5225
|
Moist steam cabinet |
Section 890.5250
|
Microwave diathermy |
Section 890.5275
|
Shortwave diathermy |
Section 890.5290
|
Ultrasonic diathermy |
Section 890.5300
|
Exercise component |
Section 890.5350
|
Measuring exercise equipment |
Section 890.5360
|
Nonmeasuring exercise equipment |
Section 890.5370
|
Powered exercise equipment |
Section 890.5380
|
Powered finger exerciser |
Section 890.5410
|
Infrared lamp |
Section 890.5500
|
Iontophoresis device |
Section 890.5525
|
Powered external limb overload warning device |
Section 890.5575
|
Powered inflatable tube massager |
Section 890.5650
|
Therapeutic massager |
Section 890.5660
|
Cold pack |
Section 890.5700
|
Hot or cold disposable pack |
Section 890.5710
|
Water circulating hot or cold pack |
Section 890.5720
|
Moist heat pack |
Section 890.5730
|
Powered heating pad |
Section 890.5740
|
Nonpowered lower extremity pressure wrap |
Section 890.5760
|
Pressure-applying device |
Section 890.5765
|
Powered muscle stimulator |
Section 890.5850
|
Ultrasound and muscle stimulator |
Section 890.5860
|
Multi-function physical therapy table |
Section 890.5880
|
Power traction equipment |
Section 890.5900
|
Traction accessory |
Section 890.5925
|
Chilling unit |
Section 890.5940
|
Powered heating unit |
Section 890.5950
|
Therapeutic vibrator |
Section 890.5975
|
Scope |