FDA.reportPublic FDA data

Tenscare

Primary DI
05033435134045
Brand
Tenscare
Company
TENSCARE LIMITED
Model
TENS One
Catalog number
K-TENSONE
Device description
TENS One is a TENS device which is commonly used to provide relief from pain associated with sore or aching muscles of the lowerback, arms, or legs due to strain from exercise or normal household and work activities.It has 3 treatment modes and is designed to be easy to use, with analog-style rotary intensity controls, digital mode selection and display, open circuit detection and keypad cover. It uses standard AA batteries and self-adhesive electrode pads. Garment glove and sock electrodes are available as optional extras.
Published
2019-08-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NUHStimulator, Nerve, Transcutaneous, Over-The-Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NUHStimulator, Nerve, Transcutaneous, Over-The-CounterNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05033435134045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05033435134045050334351340455033435134045

GMDN Terms#

Term, Definition table
TermDefinition
Analgesic transcutaneous electrical nerve stimulation systemAn assembly of electrically-powered devices designed to reduce the perception of pain by electrically stimulating peripheral nerves across the skin [transcutaneous electrical nerve stimulation (TENS)]. It includes an external current generator and skin-surface electrodes. It typically includes several predetermined stimulation options and is often worn on a belt or carried in a pocket of the user. It is intended for use in the home and healthcare facility to treat pain from surgery, trauma, musculoskeletal problems/arthritis, bursitis, dental problems, and may be used in physical therapy and during labour/delivery.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800 308 7390compliance@tenscare.com

Regulatory Flags#

DUNS number
569403736
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05033435134403TensCareKegel Fit 2K-KEGEL22024-11-18
05033435138777TensCareCool Relief Electrodes 50X50E-CR50502024-11-06
05033435138784TensCareCool Relief Electrodes 50X100E-CR501002024-11-06
05033435139118TensCareHypoallergenic ElectrodesE-TRBG2024-11-06
05033435139132TensCareCarbon Mesh Electrode pads 50X50 mmE-TR50502024-11-06
05033435139156TensCareCarbon Mesh Electrode pads 50X100 mmE-TR501002024-11-06
05033435139705TensCareBack ElectrodeE-TRALBA2024-11-06
05033435139712TensCareKnee ElectrodeK-TRALKN2024-11-06
05033435139729TensCareNeck ElectrodeE-TRALNE2024-11-06
05033435136933TensCareForm Duo2024-07-25
05033435138920TensCareOva3K-OVA32024-07-24
05033435134090TensCareOva+K-OVAP-USA2024-01-16
05033435136209TensCareUnifitK-UNIFIT2023-11-03
05033435135646TensCareUnicareK-UNICARE2023-10-24
05033435133796TensCareShockwaveK-SHOCKWAVE2023-06-08
05033435120413TensCareKneeStimK-KNEE2023-09-01
05033435000722TensCareiGlove LargeK-GL-L2023-08-31
05033435000739TensCareiSock LargeK-SK-L2023-08-31
05033435070039TensCareiTouch SureK-ITS2023-08-31
05033435120239TensCareSports TENS 2K-ST22023-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971712725908MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-07-25
00850080988657AUVONUAN HEALTHCARE LIMITEDNUH2026-07-22
06978146200117SinrelSHENZHEN SINREL TECH LTDNUH2026-07-21
06978146200124SinrelSHENZHEN SINREL TECH LTDNUH2026-07-21
00850085485090AUVONAnsion Technology (GuangDong) Co. Ltd.NUH2026-07-16
00860015112446Doctor's Choice®CLINICAL HEALTH SERVICES, INC.NUH2026-07-14
06971712725359DOMASHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-07-09
06971712722693DOMASHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-07-09
00850080988572AUVONUAN HEALTHCARE LIMITEDNUH2026-07-03
06971712727636ONENTECHHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-07-03
06978452680122AUVONShenzhen Jiantuo Electronics Co., LtdNUH2026-07-01
00850085485021AUVONAnsion Technology (GuangDong) Co. Ltd.NUH2026-06-26
00850085485038AUVONAnsion Technology (GuangDong) Co. Ltd.NUH2026-06-26
00850085485045AUVONAnsion Technology (GuangDong) Co. Ltd.NUH2026-06-26
00850085485007AVCOOAnsion Technology (GuangDong) Co. Ltd.NUH2026-06-25
00850080988473AUVONUAN HEALTHCARE LIMITEDNUH2026-06-24
00860009281806NoodlePourang Bral Dds LLCNUH2026-06-09
06978452680085AUVONShenzhen Jiantuo Electronics Co., LtdNUH2026-06-03
06978452680092AUVONShenzhen Jiantuo Electronics Co., LtdNUH2026-06-03
06978452680108NURSALShenzhen Jiantuo Electronics Co., LtdNUH2026-06-03
06971712722075MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-06-02
06971712726943MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-05-30
06971712722990SalityHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-05-28
03770018808086actiTENSSUBLIMEDNUH2026-05-27
03770018808093actiTENSSUBLIMEDNUH2026-05-27
03770018808109actiTENSSUBLIMEDNUH2026-05-27
03770018808116actiTENSSUBLIMEDNUH2026-05-27
03770018808253actiTENS MiniSUBLIMEDNUH2026-05-27
03770018808260actiTENS MiniSUBLIMEDNUH2026-05-27
00194346404155EquateWAL-MART STORES, INC.NUH2026-05-01