510(k) Report

FDA applicant

Whill, Inc.

Shinagawa-Ku, JP5 decisions2016–20262 recalls

FDA records 5 decisions for Whill, Inc. (Shinagawa-Ku, JP) from 2016 to 2026: 5 510(k) clearances. Most are in product codes ITI (Wheelchair, Powered) and INI (Vehicle, Motorized 3-Wheeled). Since 2016 its 510(k)s took a median of 63 days from receipt to decision, against 111 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 3 of them its own earlier devices. 2 recalls are linked to its devices, 2 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, physical medicine panel, where it files most

How often FDA has decided Whill, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2016: 12021: 12022: 12025: 12026 (partial year): 1
2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

2in 2025

2025: 2, 2 Class I
2016high 2 (2025) · low 0 (2016)2026

Class I Class II/III not classified

FIG. 1 — Whill, Inc. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Whill, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • ITIWheelchair, Powered4decisions
  • INIVehicle, Motorized 3-Wheeled1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 63 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 111 days; 4 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 5 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 3 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K213383WHILL Model C2Whill, Inc. · 20213cite it
  • K153543WHILL Model MWhill, Inc. · 20161cites it

What has FDA decided for it lately?

  • K261175WHILL (WHILL Model C2)Whill, Inc. · 2026
  • K242760WHILL Model RWhill, Inc. · 2025
  • K221438WHILL Model FWhill, Inc. · 20221 Class I recall
  • K213383WHILL Model C2Whill, Inc. · 20211 Class I recall
  • K153543WHILL Model MWhill, Inc. · 2016

All 5 as Whill, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K213383WHILL Model C2, with software versions before HMI: 2.22 / MC: 1.13; device is an…Dec 29, 2025Class I
  • K221438WHILL Model F, with software versions before HMI: 2.23 / MC: 1.05; the device is an…Dec 29, 2025Class I