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Profile Console

FDA UDI

Class I (US FDA UDI)

by SANUWAVE Health, Inc.

Identity

Trade Name
Profile Console FDA UDI
Generic Name
Spark-gap orthopaedic extracorporeal shock wave therapy system FDA UDI
Device Name
Profile provides mechanically assisted deep soft tissue massage through a novel form of acoustic enerfy called Diffused Acostic Pressure. FDA UDI
Model / Reference
PRF100 FDA UDI
Description
Profile provides mechanically assisted deep soft tissue massage through a novel form of acoustic enerfy called Diffused Acostic Pressure. FDA UDI

Identifiers

Primary DI / UDI-DI
00812265010287 FDA UDI
FDA Product Code
ISA FDA UDI
GMDN Term
Spark-gap orthopaedic extracorporeal shock wave therapy system FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.5660 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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Spark-gap orthopaedic extracorporeal shock wave therapy system

Profile Console by SANUWAVE Health, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Spark-gap orthopaedic 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 ff5aa378-314a-480f-978b-ba0b7c929c3a 34 fields · synced Jun 6, 2026