FDA.reportPublic FDA data

Sinrel

Primary DI
06978146200124
Brand
Sinrel
Company
SHENZHEN SINREL TECH LTD
Model
YF1581
Device description
TENS & PMS Unit
Published
2026-07-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
16978146200121PackageGS132In Commercial Distribution
26978146200128PackageGS136In Commercial Distribution
36978146200125PackageGS148In Commercial Distribution
06978146200124PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697814620012116978146200121
2697814620012826978146200128
3697814620012536978146200125
06978146200124069781462001246978146200124

Regulatory Flags#

DUNS number
618769254
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06978146200117SinrelYF15722026-07-21
06978146200100SinrelYF15662025-07-14
16978146200107SinrelYF15662025-07-14
06978146200001SinrelYF15032025-01-09
06978146200018SinrelYF1503X2025-01-09
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860015112491Therapist’s Choice®CLINICAL HEALTH SERVICES, INC.NUH2026-11-01
00810093080854PainPodHi-Dow International IncorporatedNUH2026-10-19
06971712720415CriterionHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-10-15
06971712725922DOMASHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-10-13
00850080988671AUVONUAN HEALTHCARE LIMITEDNUH2026-10-08
00850080988688AUVONUAN HEALTHCARE LIMITEDNUH2026-10-08
00850080988695AUVONUAN HEALTHCARE LIMITEDNUH2026-10-08
06978452680160ZoksiShenzhen Jiantuo Electronics Co., LtdNUH2026-09-03
06978452680153NAShenzhen Jiantuo Electronics Co., LtdNUH2026-08-26
06978452680146MedlinketShenzhen Jiantuo Electronics Co., LtdNUH2026-08-18
00850085485076AUVONAnsion Technology (GuangDong) Co. Ltd.NUH2026-08-17
00850085485106AUVONAnsion Technology (GuangDong) Co. Ltd.NUH2026-08-17
00850087184045HomedicsFKA DISTRIBUTING CO., LLCNUH2026-07-31
06924607703550Transcutaneous Electrical Nerve StimulatorsShenzhen Kentro Medical Electronics Co.,LtdNUH2026-07-31
06971712726417NourishnestHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-07-29
06971712725908MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-07-25
00850080988657AUVONUAN HEALTHCARE LIMITEDNUH2026-07-22
06978146200117SinrelSHENZHEN 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