510(k) K213383 ยท ITI Wheelchair, Powered
WHILL Model C2
| Applicant | Whill, Inc., Shinagawa-Ku, JP |
| Decision | Substantially Equivalent, Nov 9, 2021 |
| Received | Oct 13, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213383
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 24, 2026 | WHILL, INC. WHILL Model C2, with software versions before HMI: 2.22 / MC: 1.13; device is an indoor/outdoor battery-operated 2-wheel drive (rear-wheel drive) powered wheelchair. Open, Classified |
ITI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.