Therapist’s Choice® TENS 3MT TENS 3MT

GUDID 00815290016385

Therapist’s Choice® TENS 3MT, Analog Tens Unit, with Black Carrying Case

CLINICAL HEALTH SERVICES, INC.

Physical therapy transcutaneous neuromuscular electrical stimulation system
Primary Device ID00815290016385
NIH Device Record Keyc6248284-cb52-4ec0-89cb-aec9d4a10adf
Commercial Distribution StatusIn Commercial Distribution
Brand NameTherapist’s Choice® TENS 3MT
Version Model NumberTENS 3MT
Catalog NumberTENS 3MT
Company DUNS004416769
Company NameCLINICAL HEALTH SERVICES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone813-871-3120
Emailjeff@clinicalhealthservices.com
Phone813-871-3120
Emailjeff@clinicalhealthservices.com
Phone813-871-3120
Emailjeff@clinicalhealthservices.com
Phone813-871-3120
Emailjeff@clinicalhealthservices.com
Phone813-871-3120
Emailjeff@clinicalhealthservices.com
Phone813-871-3120
Emailjeff@clinicalhealthservices.com
Phone813-871-3120
Emailjeff@clinicalhealthservices.com
Phone813-871-3120
Emailjeff@clinicalhealthservices.com
Phone813-871-3120
Emailjeff@clinicalhealthservices.com
Phone813-871-3120
Emailjeff@clinicalhealthservices.com
Phone813-871-3120
Emailjeff@clinicalhealthservices.com
Phone813-871-3120
Emailjeff@clinicalhealthservices.com
Phone813-871-3120
Emailjeff@clinicalhealthservices.com
Phone813-871-3120
Emailjeff@clinicalhealthservices.com
Phone813-871-3120
Emailjeff@clinicalhealthservices.com
Phone813-871-3120
Emailjeff@clinicalhealthservices.com
Phone813-871-3120
Emailjeff@clinicalhealthservices.com
Phone813-871-3120
Emailjeff@clinicalhealthservices.com
Phone813-871-3120
Emailjeff@clinicalhealthservices.com
Phone813-871-3120
Emailjeff@clinicalhealthservices.com
Phone813-871-3120
Emailjeff@clinicalhealthservices.com
Phone813-871-3120
Emailjeff@clinicalhealthservices.com
Phone813-871-3120
Emailjeff@clinicalhealthservices.com
Phone813-871-3120
Emailjeff@clinicalhealthservices.com
Phone813-871-3120
Emailjeff@clinicalhealthservices.com
Phone813-871-3120
Emailjeff@clinicalhealthservices.com
Phone813-871-3120
Emailjeff@clinicalhealthservices.com
Phone813-871-3120
Emailjeff@clinicalhealthservices.com
Phone813-871-3120
Emailjeff@clinicalhealthservices.com
Phone813-871-3120
Emailjeff@clinicalhealthservices.com
Phone813-871-3120
Emailjeff@clinicalhealthservices.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100815290016361 [Primary]
GS100815290016378 [Package]
Contains: 00815290016361
Package: Inner Pack [5 Units]
In Commercial Distribution
GS100815290016385 [Package]
Contains: 00815290016378
Package: Master Case [8 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZJStimulator, Nerve, Transcutaneous, For Pain Relief

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-10-23
Device Publish Date2019-01-29

On-Brand Devices [Therapist’s Choice® TENS 3MT]

00815290016385Therapist’s Choice® TENS 3MT, Analog Tens Unit, with Black Carrying Case
10815290018720Therapist’s Choice® TENS 3MT: It is used for temporary relief of pain associated with sore a

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