21 CFR 888.1250 — Dynamometer, Nonpowered
Orthopedic (OR) · Part 888 Subpart B—Diagnostic Devices · § 888.1250
Identification
A nonpowered dynamometer is a mechanical device intended for medical purposes to measure the pinch and grip muscle strength of a patient's hand.
Classification Rationale
Class I. The device is exempt from the premarket notification procedures in subpart E of part 807.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HRW | Dynamometer, Nonpowered | 1 | 12 |
