510(k) Report

FDA applicant

Permobil AB

Timra, SE15 decisions1990–20208 recalls

FDA records 15 decisions for Permobil AB (Timra, SE) from 1990 to 2020: 15 510(k) clearances. Most are in product codes ITI (Wheelchair, Powered) and IPL (Wheelchair, Standup). Its devices cite 15 predicates, 9 of them its own earlier devices. 8 recalls are 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 Permobil AB’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2007: 12008: 12011: 12013: 12015: 22019: 12020: 1
2007high 2 (2015) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2025

2012: 12017: 22018: 12024: 12025: 1
2007high 2 (2017) · low 0 (2007)2026

Class I Class II/III not classified

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

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Other applicant names beginning “Permobil”

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