WHILL (WHILL Model C2)— 510(k) K261175
Substantially EquivalentWhill, Inc.
FDA 510(k) clearance K261175 for WHILL (WHILL Model C2), Substantially Equivalent on 2026-06-12. Applicant: Whill, Inc.. Device class: 2.
Summary
Whill's WHILL Model C2 is filed under ITI, powered wheelchairs. The record doesn't describe it beyond the model name and the code name.
Class II, 21 CFR 890.3860. Physical Medicine is both the classification panel and the review panel, and the submission was a Traditional 510(k).
Whill filed from Shinagawa, Japan. The decision came 63 calendar days after FDA received it (April 10 to June 12, 2026).
Clearance details
- Applicant
- Whill, Inc.
- Product code
- Product code ITI
- Device class
- Class 2
- Regulation
- 21 CFR 890.3860
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shinagawa, JP
Recent devices under product code ITI
view allMore clearances from Whill, Inc.
view allAdverse events under product code ITI
product code ITI- Death
- 34
- Injury
- 778
- Malfunction
- 1,085
- Other
- 1
- Total
- 1,898
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.