DermaPACE System

Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers

SANUWAVE, INC.

The following data is part of a De Novo classification by Sanuwave, Inc. with the FDA for Dermapace System.

Pre-market Notification Details

DeNovo IDDEN160037
Device Name:DermaPACE System
ClassificationExtracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
Applicant SANUWAVE, INC. 11475 Great Oaks Way, Ste 150 Alpharetta,  GA  30022
ContactPeter Stegagno
Product CodePZL  
CFR Regulation Number878.4685 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardGeneral & Plastic Surgery
Classification AdvisoryGeneral & Plastic Surgery
TypeDirect
Date Received2016-07-25
Decision Date2017-12-28
FDA ReviewDecision Summary
Reclassification Order:Reclassification Order

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00812265010218 DEN160037 000
00812265010201 DEN160037 000

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