ClearanceBrief
510(k) K221438 ยท ITI Wheelchair, Powered

WHILL Model F

ApplicantWhill, Inc., Shinagawa-Ku, JP
DecisionSubstantially Equivalent, Jun 7, 2022
ReceivedMay 17, 2022
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K221438

DateFirm and productCodeLinked 510(k)
Apr 24, 2026WHILL, INC.
WHILL Model F, with software versions before HMI: 2.23 / MC: 1.05; the device is an indoor/outdoor, foldable battery-operated 2-wheel drive (rear-wheel drive) powered wheelchair.
Open, Classified
ITINone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.