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dermaPACE System (Console with applicator)

SANUWAVE Health, Inc. · Model DEP0330/DAP0332 · UDI-DI 00812265010225

PZL
8
510(k) clearances
2
Adverse events
0
Recalls
16
Facilities

Description

The dermaPACE console and applicator shipped together. An assembly of devices designed to provide high-energy, spark-gap generated (electrohydraulic) extracorporeal shock wave intended to treat diabetic foot ulers.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.