Data / Medical devices / Japan / Whill, Inc.
Whill, Inc.: FDA-registered device maker in Shinagawa-ku Tokyo, Japan, 3 510(k) clearances
Whill, Inc. is registered with the FDA (registration 3021071770) in Shinagawa-ku Tokyo, Japan. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 6, 2025. 1 recall event names it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021071770
- Address
- 2-1-11 Higashi-Shinagawa Harbor Premium Building 2F, Shinagawa-ku Tokyo, Japan, 140-0002
- Owner or operator
- WHILL, Inc. (10083588)
- Roles
- Manufacturer, Specification developer
- First device listed
- December 3, 2021
- Registered through
- 2026
- Brand names listed
- WHILL Model F, WHILL Model R, Whill Model C2
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Wheelchair | KNO | 1 | Specification developer | accessdata.fda.gov |
| Vehicle, Motorized 3-Wheeled | INI | 2 | Specification developer | accessdata.fda.gov |
| Wheelchair, Powered | ITI | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 6, 2025 | K242760 | WHILL Model R | INI | Substantially Equivalent | Whill, Inc. | accessdata.fda.gov |
| June 7, 2022 | K221438 | WHILL Model F | ITI | Substantially Equivalent | Whill, Inc. | accessdata.fda.gov |
| November 9, 2021 | K213383 | WHILL Model C2 | ITI | Substantially Equivalent | Whill, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 29, 2025 | 98320 | Class I | Ongoing | 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. | Cyber vulnerability of BLE communication was found by CISA VDP program. | accessdata.fda.gov |
Compare with other makers
- All makers of Wheelchair, Powered
- All makers of Accessories, Wheelchair
- All makers of Vehicle, Motorized 3-Wheeled
Updated April 24, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.