FDA.reportPublic FDA data

Therapist’s Choice® TENS 3MT

Primary DI
00815290016385
Brand
Therapist’s Choice® TENS 3MT
Company
CLINICAL HEALTH SERVICES, INC.
Model
TENS 3MT
Catalog number
TENS 3MT
Device description
Therapist’s Choice® TENS 3MT, Analog Tens Unit, with Black Carrying Case
Published
2019-01-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
GZJStimulator, Nerve, Transcutaneous, For Pain Relief

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZJStimulator, Nerve, Transcutaneous, For Pain ReliefNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K073438000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K073438000PROSTIM 1000/2000Bio Protech, Inc.2008-02-07GZJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815290016378PackageGS15In Commercial Distribution
00815290016385PackageGS18In Commercial Distribution
00815290016361PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815290016378008152900163788152900163780815290016378
00815290016385008152900163858152900163850815290016385
00815290016361008152900163618152900163610815290016361

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy transcutaneous neuromuscular electrical stimulation systemAn electrically-powered unit intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
813-871-3120jeff@clinicalhealthservices.com

Regulatory Flags#

DUNS number
004416769
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815290017719Therapist’s Choice® TENS 7500TENS 7500Digital TENS2021-02-10
00815290013889CLINICAL HEALTH SERVICES, INC.CLIH503X-BLUECLIH503X-BLUE2016-12-09
00815290013896CLINICAL HEALTH SERVICES, INC.CLIC503X-ClearCLIC503X-Clear2016-12-07
00815290013872CLINICAL HEALTH SERVICES, INC.CLID373X-LotionCLID373X-Lotion2016-12-09
00860015112408TENSnet 3MTTENSnet 3MTTENSnet 3MT2025-12-05
10860015112405TENSnet 3MTTENSnet 3MTTENSnet 3MT2025-12-05
00815290017276Therapist’s Choice® TENS 3N1RBTENS 3N1RBTENS 3MT2020-07-06
00815290018303Therapist’s Choice® TENS 12MT Small Carrying CaseTENS 12MT Small Carrying CaseTENS 12MT2024-12-21
10815290018300Therapist’s Choice® TENS 12MT Small Carrying CaseTENS 12MT Small Carrying CaseTENS 12MT2024-12-21
00815290019409ePower® T1 TENS UNITT1 TENS UNITT1 TENS UNIT2023-09-17
00815290019416ePower® T2 DIGITAL TENST2 DIGITAL TENST2 DIGITAL TENS2023-09-17
00815290019423ePower® TE2 COMBO TENS & EMSePower® TE2 COMBO TENS & EMSePower® TE2 COMBO TENS & EMS2023-09-17
10815290019406ePower® T1 TENS UNITT1 TENS UNITT1 TENS UNIT2023-09-17
10815290019413ePower® T2 DIGITAL TENST2 DIGITAL TENST2 DIGITAL TENS2023-09-17
10815290019420ePower® TE2 COMBO TENS & EMSePower® TE2 COMBO TENS & EMSePower® TE2 COMBO TENS & EMS2023-09-17
00815290019232ePower®ePower® E1 EMS UNITePower® E1 EMS UNIT2023-07-15
00815290019249ePower®ePower® E2 DIGITAL EMSePower® E2 DIGITAL EMS2023-07-15
10815290019239ePower®ePower® E1 EMS UNITePower® E1 EMS UNIT2023-07-15
10815290019246ePower®ePower® E2 DIGITAL EMSePower® E2 DIGITAL EMS2023-07-15
00815290016361Therapist’s Choice® TENS 3MTTENS 3MTTENS 3MT2019-01-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850298007072Monitoring Lead Wires, Set of 9SOMATICS, LLCGZJ2026-05-28
03770018808086actiTENSSUBLIMEDGZJ2026-05-27
03770018808093actiTENSSUBLIMEDGZJ2026-05-27
03770018808109actiTENSSUBLIMEDGZJ2026-05-27
03770018808116actiTENSSUBLIMEDGZJ2026-05-27
03770018808253actiTENS MiniSUBLIMEDGZJ2026-05-27
03770018808260actiTENS MiniSUBLIMEDGZJ2026-05-27
00714905710024Fab StimDrive Devilbiss HealthcareGZJ2026-02-06
00810140062680RENPHOJoicom CorporationGZJ2025-10-20
00810140062697RENPHOJoicom CorporationGZJ2025-10-20
00810113683782ManaRecovery Stimulation System Manamed, Inc.GZJ2025-10-03
00810113683799ManaRecovery Stimulation System Electrode PadManamed, Inc.GZJ2025-10-03
00810113683485ManaFlexx 2 Electrodes - 4 electrodesManamed, Inc.GZJ2025-09-11
00810113683225ManaFlexx 2 Lead WiresManamed, Inc.GZJ2025-09-11
00810113683379DualPulse CompactManamed, Inc.GZJ2025-09-11
00810113683386DualPulse Compact Replacement Gel PadManamed, Inc.GZJ2025-09-11
00810113683232ManaFlexx 2 Electrodes - 10 packManamed, Inc.GZJ2025-08-21
08809851470091EVE Synergy; EVE TitanWEERO Co., Ltd.GZJ2025-06-24
00661168000037Reliefband® Sport - BlackRELIEFBAND TECHNOLOGIES LLCGZJ2025-02-24
00661168000044Reliefband® Sport - Soft GreyRELIEFBAND TECHNOLOGIES LLCGZJ2025-02-24
00661168000167Reliefband® 50 HoursRELIEFBAND TECHNOLOGIES LLCGZJ2025-02-24
00661168000181Reliefband® Premier PlusRELIEFBAND TECHNOLOGIES LLCGZJ2025-02-24
00815290018303Therapist’s Choice® TENS 12MT Small Carrying CaseCLINICAL HEALTH SERVICES, INC.GZJ2024-12-21
14897076723536E-Stim IIITENS PLUS INDUSTRIAL COMPANYGZJ2024-12-10
00810113683218ManaMedManamed, Inc.GZJ2024-04-30
B786SBM1AB0110actiTENSSUBLIMEDGZJ2024-04-24
20192253018360Uni-PatchCardinal Health 200, LLCGZJ2024-02-28
20192253018377Uni-PatchCardinal Health 200, LLCGZJ2024-02-28
B731P12T109TrueReliefTruerelief, LLCGZJ2024-01-08
00815290019409ePower® T1 TENS UNITCLINICAL HEALTH SERVICES, INC.GZJ2023-09-17