---
kind: "section"
citation: "21 C.F.R. § 888.1500"
title: "21"
number: "888.1500"
heading: "Goniometer."
url: "https://uscodex.org/cfr/21/888.1500"
---

# §888.1500. Goniometer.

- (a) **Identification.** A goniometer is an AC-powered or battery powered device intended to evaluate joint function by measuring and recording ranges of motion, acceleration, or forces exerted by a joint.
- (b) **Classification.**
  - (1) **Class I (general controls) for a goniometer that does not use electrode lead wires and patient cables.** This device is exempt from the premarket notification procedures of [subpart E of part 807](/cfr/21/part807-subpartE.md) of this chapter subject to [§ 888.9](/cfr/21/888.9.md).
  - (2) **Class II (special controls) for a goniometer that uses electrode lead wires and patient cables.** The special controls consist of:
    - (i) The performance standard under [part 898](/cfr/21/part898.md) of this chapter, and
    - (ii) The guidance entitled “Guidance on the Performance Standard for Electrode Lead Wires and Patient Cables.” This device is exempt from the premarket notification procedures of [subpart E of part 807](/cfr/21/part807-subpartE.md) of this chapter subject to [§ 888.9](/cfr/21/888.9.md).

## Notes

### Amendments

[65 FR 19319, Apr. 11, 2000]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l , 371.

### Source

Source: 52 FR 33702, Sept. 4, 1987, unless otherwise noted.

### Amendments

[65 FR 19319, Apr. 11, 2000]