510(k) Report

FDA applicant

Rehabtronics, Inc.

Edmonton, CA2 decisions2016–20210 recalls

FDA records 2 decisions for Rehabtronics, Inc. (Edmonton, CA) from 2016 to 2021: 2 510(k) clearances. Most are in product codes GZI (Stimulator, Neuromuscular, External Functional) and IPF (Stimulator, Muscle, Powered). 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, neurology panel, where it files most

How often FDA has decided Rehabtronics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2016: 12021: 1
2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

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

Planning a device like Rehabtronics, Inc.’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