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510(k) DEN160037

dermaPACE System by Sanuwave, Inc. — Product Code PZL

DEN160037 is an FDA 510(k) premarket notification submitted by Sanuwave, Inc. for the device "dermaPACE System". The FDA issued a decision of De Novo Granted on December 28, 2017. The device falls under product code PZL (Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers), a Class II device regulated under 21 CFR 878.4685.

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
December 28, 2017
Date Received
July 25, 2016
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
Device Class
Class II
Regulation Number
878.4685
Review Panel
SU
Submission Type

Treatment of diabetic foot ulcers

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FDA data resources