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dermaPACE Applicator

FDA UDI

Class II (US FDA UDI)

by SANUWAVE Health, Inc.

Identity

Trade Name
dermaPACE Applicator FDA UDI
Generic Name
Dermatological extracorporeal shock wave therapy system applicator FDA UDI
Device Name
Delivery device of Extracorporeal Shock Wave (ESW), an accessory to the dermaPACE, for the treatment of diabetic foot uclers FDA UDI
Model / Reference
DAP0332 FDA UDI
Description
Delivery device of Extracorporeal Shock Wave (ESW), an accessory to the dermaPACE, for the treatment of diabetic foot uclers FDA UDI

Identifiers

Primary DI / UDI-DI
00812265010201 FDA UDI
510(k) Number
DEN160037 FDA UDI
FDA Product Code
PZL FDA UDI
GMDN Term
Dermatological extracorporeal shock wave therapy system applicator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4685 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dermatological extracorporeal shock wave therapy system applicator

dermaPACE Applicator by SANUWAVE Health, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dermatological extracorporeal shock wave therapy system applicator.

Cleared under the same submission

DEN160037 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
SANUWAVE Health, Inc.

Sources (1)

  • FDA UDI 5e388be3-4a58-4053-a21c-cda42c1c704e 35 fields · synced Jun 8, 2026