510(k) Report

FDA applicant

Levo AG

5610 Wohlen, CH4 decisions2003–20150 recalls

FDA records 4 decisions for Levo AG (5610 Wohlen, CH) from 2003 to 2015: 4 510(k) clearances. Most are in product codes IPL (Wheelchair, Standup) and ITI (Wheelchair, Powered). Its devices cite 7 predicates, 2 of them its own earlier devices. No 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 Levo AG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2008: 12015: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Levo AG’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?

  • IPLWheelchair, Standup3decisions
  • ITIWheelchair, Powered1decision

Whose devices does it build on?

Its devices cite 7 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 2 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.

  • K051387Levo Comfort IILevo AG · 20054cite it
  • K083017LEVO C3Levo AG · 20082cite it
  • K030893Levo CombiLevo AG · 20032cite it

What has FDA decided for it lately?

All 4 as Levo AG →

Other applicant names beginning “Levo”

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

Levo USA 4Levo Medical Corporation 1