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dermaPACE System (Console with applicator)

FDA UDI

Class II (US FDA UDI)

by SANUWAVE Health, Inc.

Identity

Trade Name
dermaPACE System (Console with applicator) FDA UDI
Generic Name
Dermatological extracorporeal shock wave therapy system FDA UDI
Device Name
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. FDA UDI
Model / Reference
DEP0330/DAP0332 FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI
00812265010225 FDA UDI
FDA Product Code
PZL FDA UDI
GMDN Term
Dermatological extracorporeal shock wave therapy system 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

dermaPACE System (Console with 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.

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 42a4ff12-ddba-4207-95d6-05cec4725be2 34 fields · synced Jun 8, 2026