FDA.reportPublic FDA data

Flex-TENS

Primary DI
00858688006001
Brand
Flex-TENS
Company
Emsi
Model
FLET0001
Published
2016-09-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GZJStimulator, Nerve, Transcutaneous, For Pain Relief
LIHInterferential Current Therapy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZJStimulator, Nerve, Transcutaneous, For Pain ReliefNeurology2
LIHInterferential Current TherapyNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071869000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071869000TENS/IF 14Emsi2008-03-07GZJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858688006001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858688006001008586880060018586880060010858688006001

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

Regulatory Flags#

DUNS number
932471881
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859718007296Hypoallergenic Electrode 2x2 4pkBF50502025-12-16
00085971800729Hypoallergenic Electrode 2x2 4pkBF50502024-08-18
00858688006261TENS 3000EMS-DT30022016-09-24
00858688006285TENS 8000EMS-DT7202B2016-09-08
00858688006704TMR-ELTH-8500A85002016-10-14
00858688006964Electrode 45 x 45 16 PKELEC0019B2023-09-20
00858688006971Electrode 1.75 x 1.75 4 pack ELEC0008B2023-09-20
00859718007074Electrode 1.75 x 1.75 - 24 PKELEC0028B2023-09-20
00859718007081Electrode 4.0 x 7.0- DispersiveELEC407001B2023-09-20
00859718007098Electrode 1 Inch Round 4 PKSRELEC0001B2023-09-20
00859718007104"Electrode 2"" round 4pk"SRELEC0002B2023-09-20
00859718007111Electrode 3 Inch Round 4PKSRELEC0003B2023-09-20
00859718007135Electrode 2 x 4 Inch Rectangle SRELEC0005B2023-09-20
00859718007142Electrode 2 x 2 inch Square 4PKSRELC0015B2023-09-20
00859718007159Electrode 1.75 Inch SquareSRELEC0016B2023-09-20
00859718007289Flex-MI with ElectrodesFLEMC00012023-09-20
00859718007272Flex-MIFLEMC00012023-09-19
00858688006018Flex-ITFLEI00012016-09-02
00858688006025Flex-MT PlusFLEMP00012016-09-02
00858688006032IF-5000SRCOMBO2016-10-07

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
08032625824480GLOBUSDOMINO SRLLIH2026-02-23
00714905117649Fab StimDrive Devilbiss HealthcareLIH2026-02-06
00714905710024Fab StimDrive Devilbiss HealthcareLIH2026-02-06
00714905710024Fab StimDrive Devilbiss HealthcareGZJ2026-02-06
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
14897076723536E-Stim IIITENS PLUS INDUSTRIAL COMPANYGZJ2024-12-10
08032625822868GLOBUSDOMINO SRLLIH2024-11-20
08032625822875GLOBUSDOMINO SRLLIH2024-11-20
08032625822882GLOBUSDOMINO SRLLIH2024-11-20
08032625822851GLOBUSDOMINO SRLLIH2024-10-17
08032625828037GLOBUSDOMINO SRLLIH2024-10-17
08032625829799GLOBUSDOMINO SRLLIH2024-10-17
08032625829805GLOBUSDOMINO SRLLIH2024-10-17
08032625829812GLOBUSDOMINO SRLLIH2024-10-17
08032625822837GLOBUSDOMINO SRLLIH2024-09-04
08032625822844GLOBUSDOMINO SRLLIH2024-09-04
08032625825265GLOBUSDOMINO SRLLIH2024-09-04
08032625828020GLOBUSDOMINO SRLLIH2024-09-04
00810113683218ManaMedManamed, Inc.GZJ2024-04-30