Transcutaneous Electrical Nerve Stimulator

GUDID 06924607701600

Shenzhen Kentro Medical Electronics Co.,Ltd

Analgesic transcutaneous electrical nerve stimulation system
Primary Device ID06924607701600
NIH Device Record Keyfe3f7c76-26ed-47b7-9e07-87917f68e5e1
Commercial Distribution StatusIn Commercial Distribution
Brand NameTranscutaneous Electrical Nerve Stimulator
Version Model NumberKTR-208
Company DUNS544395368
Company NameShenzhen Kentro Medical Electronics Co.,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 Batchtrue
Serial Numbertrue
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
GS106924607701600 [Primary]

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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-10-23
Device Publish Date2019-10-11

On-Brand Devices [Transcutaneous Electrical Nerve Stimulator]

06924607701624KTR-206
06924607701617KTR-209
06924607701600KTR-208
06924607702652KTR-405
06924607702911KTR-4031
06924607702799KTR-4039
06924607702782KTR-4037
06924607702775KTR-4036
06924607702768KTR-4034
06924607702751KTR-4032
06924607702744KTR-4029
06924607702737KTR-4027
06924607702720KTR-4026
06924607702713KTR-4021
06924607702706KTR-4015
06924607702683KTR-4012

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