510(k) Report

FDA applicant

Altimate Medical, Inc.

Morton, MN2 decisions2009–20131 recall

FDA records 2 decisions for Altimate Medical, Inc. (Morton, MN) from 2009 to 2013: 2 510(k) clearances. All are in product code INO (Chair, Positioning, Electric). Its devices cite 2 predicates, 1 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 Altimate Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2009: 12013: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2022

2022: 1
2009high 1 (2022) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Altimate Medical, Inc. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • INOChair, Positioning, Electric2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K091242BantamAltimate Medical, Inc. · 20091cites it

What has FDA decided for it lately?

  • K123834Easystand Bantam MediumAltimate Medical, Inc. · 2013
  • K091242BantamAltimate Medical, Inc. · 20091 recall

All 2 as Altimate Medical, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K091242EasyStand Bantam, with the following sizes. a. Small; b. Extra Small. Used for assisting…Oct 4, 2022Class II