FDA-recognized standard · Physical Medicine
ISO 7176-21: Wheelchairs -- Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters and battery chargers
Yes. FDA recognizes ISO 7176-21 Third edition 2025-04 as recognition 16-240, entered 2026-05-25. FDA also lists ISO 7176-21 Second edition 2009-04-01 (recognition 16-166, transition period ending 2028-07-02).
Recognized editions of ISO 7176-21
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 16-240 | ISO 7176-21 Third edition 2025-04 | 2026-05-25 | Complete | — |
| 16-166 | ISO 7176-21 Second edition 2009-04-01 | 2022-05-30 | Partial | 2028-07-02 |
What FDA does not recognize in ISO 7176-21 Second edition 2009-04-01
Recognition 16-166 is partial. FDA's statement of the extent, verbatim:
Partial recognition. The following part(s) of the standard is (are) not recognized: Clause 5.2.2 Electrostatic discharge immunity Clause 5.2.3 Radiated r.f. field immunity Clause 5.2.4 Power frequency magnetic field immunity Clause 5.3.5 Electrostatic discharge immunity Clause 5.3.6 Radiated r.f. field immunity Clause 5.4.5 Electrostatic discharge immunity Clause 5.4.6 Radiated r.f. field immunity
Regulations
FDA lists these classification regulations against ISO 7176-21: 21 CFR 890.3800, 21 CFR 890.3850, 21 CFR 890.3860, 21 CFR 890.3880, 21 CFR 890.3890, 21 CFR 890.3900, 21 CFR 890.3930.
Product codes that cite ISO 7176-21
7 FDA product codes cite ISO 7176-21, including IMK, ING, INI, IOR, IPL.
- IMK
- ING
- INI Vehicle, Motorized 3-Wheeled
- IOR Wheelchair, Mechanical
- IPL Wheelchair, Standup
- IQC
- ITI Wheelchair, Powered
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.