21 CFR 888.1520 — Goniometer, Nonpowered
Orthopedic (OR) · Part 888 Subpart B—Diagnostic Devices · § 888.1520
Identification
A nonpowered goniometer is a mechanical device intended for medical purposes to measure the range of motion of joints.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KQW | Goniometer, Nonpowered | 1 | 13 | |
| LZE | Isometer | 1 | 1 |
