510(k) Report

FDA applicant

Alber GmbH

Albstadt, DE5 decisions2016–20220 recalls

FDA records 5 decisions for Alber GmbH (Albstadt, DE) from 2016 to 2022: 5 510(k) clearances. All are in product code ITI (Wheelchair, Powered). Since 2016 its 510(k)s took a median of 243 days from receipt to decision, against 173 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 4 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 Alber GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2016: 22020: 22022: 1
2016high 2 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Alber GmbH by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Alber”

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