510(k) Report

FDA applicant

Gunnell, Inc.

Millington, MI1 decision2012–20121 recall

FDA records 1 decision for Gunnell, Inc. (Millington, MI) in 2012: 1 510(k) clearance. All are in product code IOR (Wheelchair, Mechanical). Its devices cite 5 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices.

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 Gunnell, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2012: 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

1in 2013

2013: 1
2012high 1 (2013) · low 0 (2012)2026

Class I Class II/III not classified

FIG. 1 — Gunnell, Inc. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • IORWheelchair, Mechanical1decision

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K111636Rehab TNT, Rehab Ram, Rehab Mac, Rehab Kidster, Bariatric Rehab TNT and Rehab RamGunnell, Inc. · 20121 recall

The one decision as Gunnell, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K111636Chenica Gunnell Rehab Series of Wheelchairs (GRSW); Mechanical Wheelchair, Sold as Rehab…Jan 18, 2013Class II