QKC · Interactive Rehabilitation Exercise Device, Prescription Use
Physical Medicine · 21 CFR 890.5360 · Class 2
Overview
| Product Code | QKC |
|---|---|
| Device Name | Interactive Rehabilitation Exercise Device, Prescription Use |
| Regulation | 21 CFR 890.5360 |
| Device Class | Class 2 |
| Review Panel | Physical Medicine |
Identification
Measuring exercise equipment consist of manual devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. These devices also include instrumentation, such as the pulse rate monitor, that provide information used for physical evaluation and physical planning purposes., Examples include a therapeutic exercise bicycle with measuring instrumentation, a manually propelled treadmill with measuring instrumentation, and a rowing machine with measuring instrumentation.
Classification Rationale
Class II (special controls). The device, when it is a measuring exerciser or an interactive rehabilitation exercise device for prescription use only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.
Special Controls
*Classification.* Class II (special controls). The device, when it is a measuring exerciser or an interactive rehabilitation exercise device for prescription use only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
