FDA-recognized standard · Neurology
IEC 60601-2-10: Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
Yes. FDA recognizes IEC 60601-2-10 Edition 2.2 2023-01 CONSOLIDATED VERSION as recognition 17-22, entered 2025-05-26. FDA also lists IEC 60601-2-10 Edition 2.1 2016-04 (recognition 17-16, transition period ending 2028-07-02).
Recognized editions of IEC 60601-2-10
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 17-22 | IEC 60601-2-10 Edition 2.2 2023-01 CONSOLIDATED VERSION | 2025-05-26 | Complete | — |
| 17-16 | IEC 60601-2-10 Edition 2.1 2016-04 | 2018-06-07 | Complete | 2028-07-02 |
Regulations
FDA lists these classification regulations against IEC 60601-2-10: 21 CFR 882.1871, 21 CFR 882.5890, 21 CFR 890.5850, 21 CFR 890.5851.
Product codes that cite IEC 60601-2-10
11 FDA product codes cite IEC 60601-2-10, including GZJ, IPF, LIH, NGX, NUH.
- GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
- IPF Stimulator, Muscle, Powered
- LIH
- NGX Stimulator, Muscle, Powered, For Muscle Conditioning
- NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
- NUW
- NYN
- NYY
- NYZ
- SDO
- SDX
Source: FDA Recognized Consensus Standards database, snapshot of 2026-09-01. Search every recognition in the Consensus Standards Lookup, or browse all standards with a page.