FDA applicant

Bioness, Inc.

Valencia, CA13 decisions2011–20220 recalls

FDA records 13 decisions for Bioness, Inc. (Valencia, CA) from 2011 to 2022: 13 510(k) clearances. Most are in product codes GZI (Stimulator, Neuromuscular, External Functional) and GZF (Stimulator, Peripheral Nerve, Implanted (Pain…). Its devices cite 16 predicates, 10 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, neurology panel, where it files most

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

FDA decisions per year

1in 2022

2011high 3 (2019) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Bioness, Inc. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Bioness, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?