Profile Console

GUDID 00812265010287

Spark-gap orthopaedic extracorporeal shock wave therapy system

Primary Device ID	00812265010287
NIH Device Record Key	ff5aa378-314a-480f-978b-ba0b7c929c3a
Commercial Distribution Status	In Commercial Distribution
Brand Name	Profile Console
Version Model Number	PRF100
Company DUNS	832217439
Company Name	Sanuwave, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00812265010287 [Primary]

ISA	Massager, Therapeutic, Electric

Steralize Prior To Use	false
Device Is Sterile	false

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00812265010225 - dermaPACE System (Console with applicator)	2021-02-02 The dermaPACE console and applicator shipped together. An assembly of devices designed to provide high-energy, spark-gap generat
00812265010287 - Profile Console	2021-02-02Profile provides mechanically assisted deep soft tissue massage through a novel form of acoustic enerfy called Diffused Acostic Pressure.
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00812265010294 - Profile Applicator	2021-02-02 Profile Hand-held Treatment Applicator designed to use with Profile Control Console (PRF100)
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00812265010317 - UltraMIST Generator	2021-02-02 The UltraMIST Generator
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