FDA.reportPublic FDA data

Etekcity TENS Unit

Primary DI
00817915020012
Brand
Etekcity TENS Unit
Company
Vesync (US) Corporation
Model
ETU-134
Published
2019-04-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
NGXStimulator, Muscle, Powered, For Muscle Conditioning
NUHStimulator, Nerve, Transcutaneous, Over-The-Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NGXStimulator, Muscle, Powered, For Muscle ConditioningPhysical Medicine2
NUHStimulator, Nerve, Transcutaneous, Over-The-CounterNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130802000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130802000OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060)Shenzhen Dongdixin Technology Co., Ltd.2013-09-16NUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817915020019PackageGS140In Commercial Distribution
00817915020012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081791502001910817915020019
00817915020012008179150200128179150200120817915020012

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

Regulatory Flags#

DUNS number
079578783
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817915020272Etekcity Smart Fitness ScaleEFS-A791-KUS2026-05-11
00817915020043ETEKCITY TENS Unit Electrode Pads(50x50mm)ETU-P122019-09-20
00817915020050ETEKCITY TENS Unit Electrode Pads(50x100mm)ETU-P122019-09-20
00817915020067Etekcity Smart Fitness ScaleESF932019-10-10
00817915020074Etekcity Smart Fitness ScaleFIT 8S2019-12-20
00817915020098Etekcity Smart Fitness ScaleESF172020-06-01
00817915020104Etekcity Smart Fitness ScaleESF182020-06-01
00817915020111Etekcity Smart Fitness ScaleESF242020-06-01
00817915020128Etekcity Smart Fitness ScaleESF282020-06-01
00817915020135Etekcity Smart Fitness ScaleESF372020-06-01
00817915020166Etekcity Smart Fitness ScaleESF14, ESF382020-08-01
00817915020180Etekcity Smart Fitness ScaleESF-5512021-05-31
00817915020197EtekcityEFS-E661-WUS2024-08-24
00817915020203EtekcityEFS-E661-KUS2024-08-24
00817915020210EtekcityEFS-A591S-KUST2024-11-04
00817915020234EtekcityEFS-C671-WUST2025-01-14
00817915020258Etekcity Neck Massager Heated ProENM-C221-WUS2025-03-31
00817915020265Etekcity Smart Fitness ScaleEFS-C651-WUS2025-07-01
00817915023211Etekcity Smart Fitness ScaleESF932024-03-22
00817915028216Etekcity Smart Fitness ScaleEFS-A591S-WUST2021-08-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850080988572AUVONUAN HEALTHCARE LIMITEDNUH2026-07-03
00850080988572AUVONUAN HEALTHCARE LIMITEDNGX2026-07-03
06971712727636ONENTECHHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-07-03
06971712727636ONENTECHHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-07-03
00860009281806NoodlePourang Bral Dds LLCNUH2026-06-09
06978452680085AUVONShenzhen Jiantuo Electronics Co., LtdNGX2026-06-03
06978452680085AUVONShenzhen Jiantuo Electronics Co., LtdNUH2026-06-03
06978452680092AUVONShenzhen Jiantuo Electronics Co., LtdNGX2026-06-03
06978452680092AUVONShenzhen Jiantuo Electronics Co., LtdNUH2026-06-03
06978452680108NURSALShenzhen Jiantuo Electronics Co., LtdNGX2026-06-03
06978452680108NURSALShenzhen Jiantuo Electronics Co., LtdNUH2026-06-03
06971712722075MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-06-02
06971712722075MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-06-02
06971712726943MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-05-30
06971712726943MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-05-30
06971712722990SalityHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-05-28
06971712722990SalityHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-05-28
03770018808086actiTENSSUBLIMEDNUH2026-05-27
03770018808086actiTENSSUBLIMEDNGX2026-05-27
03770018808093actiTENSSUBLIMEDNUH2026-05-27
03770018808093actiTENSSUBLIMEDNGX2026-05-27
03770018808109actiTENSSUBLIMEDNUH2026-05-27
03770018808109actiTENSSUBLIMEDNGX2026-05-27
03770018808116actiTENSSUBLIMEDNUH2026-05-27
03770018808116actiTENSSUBLIMEDNGX2026-05-27
03770018808253actiTENS MiniSUBLIMEDNUH2026-05-27
03770018808253actiTENS MiniSUBLIMEDNGX2026-05-27
03770018808260actiTENS MiniSUBLIMEDNGX2026-05-27
03770018808260actiTENS MiniSUBLIMEDNUH2026-05-27
00199874125305Muscle StimulatorShenzhen Yiran Intelligence Co., Ltd.NGX2026-05-08