---
kind: "section"
citation: "21 C.F.R. § 890.1175"
title: "21"
number: "890.1175"
heading: "Electrode cable."
url: "https://uscodex.org/cfr/21/890.1175"
---

# §890.1175. Electrode cable.

- (a) **Identification.** An electrode cable is a device composed of strands of insulated electrical conductors laid together around a central core and intended for medical purposes to connect an electrode from a patient to a diagnostic machine.
- (b) **Classification.** Class II (special controls). The special controls consist of:
  - (1) The performance standard under [part 898](/cfr/21/part898.md) of this chapter, and
  - (2) The guidance document 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 [§ 890.9](/cfr/21/890.9.md).

## Notes

### Amendments

[48 FR 53047, Nov. 23, 1983, as amended at 59 FR 63014, Dec. 7, 1994; 65 FR 19319, Apr. 11, 2000]

### Authority

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

### Source

Source: 48 FR 53047, Nov. 23, 1983, unless otherwise noted.

### Amendments

[48 FR 53047, Nov. 23, 1983, as amended at 59 FR 63014, Dec. 7, 1994; 65 FR 19319, Apr. 11, 2000]