510(k) Report

FDA applicant

Otto Bock, Austria GmbH

St Paul, MN2 decisions2009–20140 recalls

FDA records 2 decisions for Otto Bock, Austria GmbH (St Paul, MN) from 2009 to 2014: 2 510(k) clearances. Most are in product codes IPF (Stimulator, Muscle, Powered) and GXY (Electrode, Cutaneous). Its devices cite 7 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Otto Bock Austria”.

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 Otto Bock, Austria GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2009: 12014: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Otto Bock, Austria GmbH by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Otto Bock, Austria GmbH’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?

  • IPFStimulator, Muscle, Powered1decision
  • GXYElectrode, Cutaneous1decision

Whose devices does it build on?

Its devices cite 7 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 13 times; 0 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.

  • K080950Stiwell MED4Otto Bock, Austria GmbH · 20098cite it
  • K123795Axon-Bus Prosthetic SystemOtto Bock Austria · 20145cite it

What has FDA decided for it lately?

  • K123795Axon-Bus Prosthetic SystemOtto Bock Austria · 2014
  • K080950Stiwell MED4Otto Bock, Austria GmbH · 2009

The one decision as Otto Bock, Austria GmbH →The one decision as Otto Bock Austria →

Other applicant names beginning “Otto”

FDA records each applicant name separately; these may or may not be the same firm.

Otto Bock Healthcare LP 17Otto Bock Orthopedic Industry, Inc. 6Otto Bock Healthcare Products GmbH 3Otto Bock Pur Life Science GmbH 1Otto Back Healthcare, LP 1Otto C. Watzka 1Otto Bock Orthopaedische Industrie, Kg. 1