FDA.reportPublic FDA data

Therapist’s Choice® TENS 3MT

Primary DI
00815290016361
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

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 device assembly 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; it is not intended for tremor suppression. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation.

Contacts#

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

Regulatory Flags#

DUNS number
004416769
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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
00815290016552Therapist’s Choice® EMS 250EMS 250EMS 2502019-08-02

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