e-CFR Navigation Aids


Simple Search

Advanced Search

 — Boolean

 — Proximity


Search History

Search Tips


Latest Updates

User Info


Agency List

Incorporation By Reference

eCFR logo

Related Resources

Electronic Code of Federal Regulations

We invite you to try out our new beta eCFR site at https://ecfr.federalregister.gov. We have made big changes to make the eCFR easier to use. Be sure to leave feedback using the Help button on the bottom right of each page!

e-CFR data is current as of September 17, 2020

Title 21Chapter ISubchapter HPart 890Subpart B → §890.1175

Title 21: Food and Drugs
Subpart B—Physical Medicine Diagnostic Devices

§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 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 of this chapter subject to §890.9.

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

Need assistance?