FDA applicant

Niveus Medical, Inc.

Mountain View, CA2 decisions2013–20150 recalls

FDA records 2 decisions for Niveus Medical, Inc. (Mountain View, CA) from 2013 to 2015: 2 510(k) clearances. All are in product code IPF (Stimulator, Muscle, Powered). Its devices cite 4 predicates, 1 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 Niveus Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Niveus Medical, Inc. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Niveus Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Niveus Medical, Inc.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?