Shinagawa-Ku, JP · 4 510(k) clearances · 2 recalls (2 Class I)
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| ITI | Wheelchair, Powered | Class II | Physical Medicine | 3 | 2026-06-12 |
| INI | Vehicle, Motorized 3-Wheeled | Class II | Physical Medicine | 1 | 2025-01-06 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2025-12-29 | Class I | Ongoing | Z-1827-2026 | WHILL Model F, with software versions before HMI: 2.23 / MC: 1.05; the device is an indoor/outdoor, foldable battery-ope… | — | Cyber vulnerability of BLE communication was found by CISA VDP program. |
| 2025-12-29 | Class I | Ongoing | Z-1826-2026 | WHILL Model C2, with software versions before HMI: 2.22 / MC: 1.13; device is an indoor/outdoor battery-operated 2-wheel… | — | Cyber vulnerability of BLE communication was found by CISA VDP program. |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-06-12 | K261175 | WHILL (WHILL Model C2) | ITI | Class II | Physical Medicine |
| 2025-01-06 | K242760 | WHILL Model R | INI | Class II | Physical Medicine |
| 2022-06-07 | K221438 | WHILL Model F | ITI | Class II | Physical Medicine |
| 2021-11-09 | K213383 | WHILL Model C2 | ITI | Class II | Physical Medicine |