510(k) Report

FDA applicant

Sanuwave, Inc.

Alpharetta, GA2 decisions2000–20170 recalls

FDA records 2 decisions for Sanuwave, Inc. (Alpharetta, GA) from 2000 to 2017: 1 De Novo grant and 1 original PMA approval. Most are in product codes PZL (Extracorporeal Shock Wave Device For Treatment…) and NBN (Generator, Shock-Wave, For Pain Relief). 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

1in 2017

2017: 1
2007high 1 (2017) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sanuwave, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sanuwave, 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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Which product codes does it file in?

  • PZLExtracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers1decision
  • NBNGenerator, Shock-Wave, For Pain Relief1decision

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • DEN160037dermaPACE SystemSanuwave, Inc. · 20172cite it

What has FDA decided for it lately?

  • DEN160037dermaPACE SystemSanuwave, Inc. · 2017
  • P990086Healthtronics OssatronSanuwave, Inc. · 2000

All 2 as Sanuwave, Inc. →