21 CFR 890.1925 — System, Isokinetic Testing And Evaluation
Physical Medicine (PM) · Part 890 Subpart B—Physical Medicine Diagnostic Devices · § 890.1925
Identification
An isokinetic testing and evaluation system is a rehabilitative exercise device intended for medical purposes, such as to measure, evaluate, and increase the strength of muscles and the range of motion of joints.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| IKK | System, Isokinetic Testing And Evaluation | 2 | 61 |
Special Controls
IKK — System, Isokinetic Testing And Evaluation
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.
eCFR
