dermaPACE Console

GUDID 00812265010218

Energy generator and control unit ( t be used in conjuction with the PACE Applicator) for the delivery of Extracorporeal Shock Waves (ESW) for the treatment of Diabetic Foot Ulcers.

Sanuwave, Inc.

Dermatological extracorporeal shock wave therapy system Dermatological extracorporeal shock wave therapy system Dermatological extracorporeal shock wave therapy system Dermatological extracorporeal shock wave therapy system Dermatological extracorporeal shock wave therapy system Dermatological extracorporeal shock wave therapy system Dermatological extracorporeal shock wave therapy system Dermatological extracorporeal shock wave therapy system Dermatological extracorporeal shock wave therapy system Dermatological extracorporeal shock wave therapy system Dermatological extracorporeal shock wave therapy system Dermatological extracorporeal shock wave therapy system Dermatological extracorporeal shock wave therapy system Dermatological extracorporeal shock wave therapy system Dermatological extracorporeal shock wave therapy system Dermatological extracorporeal shock wave therapy system Dermatological extracorporeal shock wave therapy system Dermatological extracorporeal shock wave therapy system Dermatological extracorporeal shock wave therapy system Dermatological extracorporeal shock wave therapy system Dermatological extracorporeal shock wave therapy system Dermatological extracorporeal shock wave therapy system Dermatological extracorporeal shock wave therapy system Dermatological extracorporeal shock wave therapy system Dermatological extracorporeal shock wave therapy system Dermatological extracorporeal shock wave therapy system Dermatological extracorporeal shock wave therapy system Dermatological extracorporeal shock wave therapy system
Primary Device ID00812265010218
NIH Device Record Keyc201d920-1f57-4d79-b486-a533c5cdf2de
Commercial Distribution StatusIn Commercial Distribution
Brand NamedermaPACE Console
Version Model NumberDEP0330
Company DUNS832217439
Company NameSanuwave, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone678-578-0108
Emailoder@sanuwave.com
Phone678-578-0108
Emailoder@sanuwave.com
Phone678-578-0108
Emailoder@sanuwave.com
Phone678-578-0108
Emailoder@sanuwave.com
Phone678-578-0108
Emailoder@sanuwave.com
Phone678-578-0108
Emailoder@sanuwave.com
Phone678-578-0108
Emailoder@sanuwave.com
Phone678-578-0108
Emailoder@sanuwave.com
Phone678-578-0108
Emailoder@sanuwave.com
Phone678-578-0108
Emailoder@sanuwave.com
Phone678-578-0108
Emailoder@sanuwave.com
Phone678-578-0108
Emailoder@sanuwave.com
Phone678-578-0108
Emailoder@sanuwave.com
Phone678-578-0108
Emailoder@sanuwave.com
Phone678-578-0108
Emailoder@sanuwave.com
Phone678-578-0108
Emailoder@sanuwave.com
Phone678-578-0108
Emailoder@sanuwave.com
Phone678-578-0108
Emailoder@sanuwave.com
Phone678-578-0108
Emailoder@sanuwave.com
Phone678-578-0108
Emailoder@sanuwave.com
Phone678-578-0108
Emailoder@sanuwave.com
Phone678-578-0108
Emailoder@sanuwave.com
Phone678-578-0108
Emailoder@sanuwave.com
Phone678-578-0108
Emailoder@sanuwave.com
Phone678-578-0108
Emailoder@sanuwave.com
Phone678-578-0108
Emailoder@sanuwave.com
Phone678-578-0108
Emailoder@sanuwave.com
Phone678-578-0108
Emailoder@sanuwave.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100812265010218 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PZLExtracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-02
Device Publish Date2021-01-25

Devices Manufactured by Sanuwave, Inc.

00812265010201 - dermaPACE Applicator2021-02-02 Delivery device of Extracorporeal Shock Wave (ESW), an accessory to the dermaPACE, for the treatment of diabetic foot uclers
00812265010218 - dermaPACE Console2021-02-02Energy generator and control unit ( t be used in conjuction with the PACE Applicator) for the delivery of Extracorporeal Shock Waves (ESW) for the treatment of Diabetic Foot Ulcers.
00812265010218 - dermaPACE Console2021-02-02 Energy generator and control unit ( t be used in conjuction with the PACE Applicator) for the delivery of Extracorporeal Shock W
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 Console2021-02-02 Profile provides mechanically assisted deep soft tissue massage through a novel form of acoustic enerfy called Diffused Acostic
00812265010294 - Profile Applicator 2021-02-02 Profile Hand-held Treatment Applicator designed to use with Profile Control Console (PRF100)
00812265010300 - Profile Applicator 2021-02-02 Profile Hand-held Treatment Applicator designed to use with Profile Control Console (PRF100)
00812265010317 - UltraMIST Generator2021-02-02 The UltraMIST Generator
00812265010324 - UltraMIST Treatment Wand2021-02-02 Component to the UltraMIST System
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.