510(k) Report

FDA applicant

Karman Healthcare, Inc.

La Puente, CA3 decisions1995–20001 recall

FDA records 3 decisions for Karman Healthcare, Inc. (La Puente, CA) from 1995 to 2000: 3 510(k) clearances. All are in product code IOR (Wheelchair, Mechanical). 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 Karman Healthcare, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Karman Healthcare, Inc. since 2007.

Recalls per year

1in 2016

2016: 1
2007high 1 (2016) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Karman Healthcare, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • IORWheelchair, Mechanical3decisions

What has FDA decided for it lately?

  • K002202Karman WheelchairKarman Healthcare, Inc. · 2000
  • K002167Karman WheelchairKarman Healthcare, Inc. · 20001 recall
  • K950195Karma WheelchairKarman Healthcare, Inc. · 1995

All 3 as Karman Healthcare, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K002167Karma Flexx Wheelchair Manual Wheelchair.Jan 27, 2016Class II