FDA applicant

Nanovibronix, Inc.

Elmsford, NY2 decisions2012–20220 recalls

FDA records 2 decisions for Nanovibronix, Inc. (Elmsford, NY) from 2012 to 2022: 2 510(k) clearances. Most are in product codes PFW (Stationary Ultrasonic Diathermy Device For Use…) and OMP (Negative Pressure Wound Therapy Powered…). Its devices cite 2 predicates, 0 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 Nanovibronix, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Nanovibronix, Inc. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Nanovibronix, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?