N/A

GUDID 80092237616747

SoundCare Plus - Professional

Roscoe Medical

Physical therapy ultrasound system
Primary Device ID80092237616747
NIH Device Record Key417802f9-92fe-4f95-9d5d-15f0c352e0d5
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model NumberDQ9275
Company DUNS022542271
Company NameRoscoe Medical
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 Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone440-572-1962
EmailCustomerService@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100092237616741 [Primary]
GS180092237616747 [Package]
Contains: 00092237616741
Package: CA [3 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IMGStimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-10-12

On-Brand Devices [N/A]

80813520011939InTENSity 10 Digital TENS
80813520010772TENS 3000 Analog
80813520010468Electrode - Foil - 2x2 - White
01813520010430Electrode - Foil - 2 - White
80813520010345K120 Electrode, Poly Bag 2 x
00813520010042Electrode - Foil - 2 - Tan
80813520010024Tan Cloth Electrodes w/ Tyco
800922376164405cm Sound Head - 2nd Gen
80092237618239Leadwire
00092237618226SoundCare Plus - Wand, 5 cm
00092237618219SoundCare Plus - Wand, 1 cm
80092237617515InTENSity Twin Stim
01092237617389CX4 & EX4 Clinical Leadwires
8009223761737978 Single (Combination) Lead
0109223761736578 Clinical Lead Wires
80092237617348Lead Wires for Quattro 2/2.5 &
80092237616761TwinStim Plus 2nd Edition
80092237616754Twin Stim 2nd - TENS/EMS
80092237616747SoundCare Plus - Professional
80092237616709InTENSity Select Combo -
80092237616686InTENSity IF Combo (TENS/IF)
80092237616655EMS 7500 2nd Gen - Digital EMS
800922376164331cm Sound Head - 2nd Gen
80092237611629Quattro 2.5
80092237605468ComboCare E-Stim and
80092237617386CX4 & EX4 Clinical Leadwires
8009223761736278 Clinical Lead Wires

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