Sinrel

GUDID 16978146200053

TENS & PMS Unit

SHENZHEN SINREL TECH LTD

Analgesic transcutaneous electrical nerve stimulation system
Primary Device ID16978146200053
NIH Device Record Key3e057ff0-fb07-40c7-882a-916b42e5d244
Commercial Distribution StatusIn Commercial Distribution
Brand NameSinrel
Version Model NumberYF1510
Company DUNS618769254
Company NameSHENZHEN SINREL TECH LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS106978146200056 [Primary]
GS116978146200053 [Package]
Contains: 06978146200056
Package: [32 Units]
In Commercial Distribution
GS126978146200050 [Package]
Contains: 06978146200056
Package: [36 Units]
In Commercial Distribution
GS136978146200057 [Package]
Contains: 06978146200056
Package: [48 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NUHStimulator, Nerve, Transcutaneous, Over-The-Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-01-17
Device Publish Date2025-01-09

On-Brand Devices [Sinrel]

16978146200091TENS & PMS Unit
16978146200084TENS & PMS Unit
16978146200077TENS & PMS Unit
16978146200060TENS & PMS Unit
16978146200053TENS & PMS Unit
16978146200046TENS & PMS Unit
16978146200039TENS & PMS Unit
16978146200022TENS & PMS Unit
16978146200015TENS & PMS Unit
16978146200008TENS & PMS Unit

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