FDA.reportPublic FDA data

Sinrel

Primary DI
06978146200018
Brand
Sinrel
Company
SHENZHEN SINREL TECH LTD
Model
YF1503X
Device description
TENS & PMS Unit
Published
2025-01-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220005000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220005000TENS & PMS UnitShenzhen Yuehua Xinsen Technology Co., Ltd.2022-04-01NUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16978146200015PackageGS132In Commercial Distribution
26978146200012PackageGS136In Commercial Distribution
36978146200019PackageGS148In Commercial Distribution
06978146200018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697814620001516978146200015
2697814620001226978146200012
3697814620001936978146200019
06978146200018069781462000186978146200018

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.

Regulatory Flags#

DUNS number
618769254
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06978146200100SinrelYF15662025-07-14
16978146200107SinrelYF15662025-07-14
06978146200001SinrelYF15032025-01-09
06978146200025SinrelYF15042025-01-09
06978146200032SinrelYF1504V2025-01-09
06978146200049SinrelYF1508C2025-01-09
06978146200056SinrelYF15102025-01-09
06978146200063SinrelYF15112025-01-09
06978146200070SinrelYF15122025-01-09
06978146200087SinrelYF15132025-01-09
06978146200094SinrelTENS XS PRO2025-01-09
16978146200008SinrelYF15032025-01-09
16978146200015SinrelYF1503X2025-01-09
16978146200022SinrelYF15042025-01-09
16978146200039SinrelYF1504V2025-01-09
16978146200046SinrelYF1508C2025-01-09
16978146200053SinrelYF15102025-01-09
16978146200060SinrelYF15112025-01-09
16978146200077SinrelYF15122025-01-09
16978146200084SinrelYF15132025-01-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00850044118762iHealthiHealth Labs Inc.NUH2026-04-16
00850016867209Pixie CupPixie Cup LLCNUH2025-11-05
00810140062680RENPHOJoicom CorporationNUH2025-10-20
00810140062697RENPHOJoicom CorporationNUH2025-10-20