Low-Frequency Therapy Instrument

GUDID 06924607700535

Shenzhen Kentro Medical Electronics Co.,Ltd

Analgesic transcutaneous electrical nerve stimulation system
Primary Device ID06924607700535
NIH Device Record Key90d57e6e-eb96-4a4e-a569-4d572f4df694
Commercial Distribution StatusIn Commercial Distribution
Brand NameLow-Frequency Therapy Instrument
Version Model NumberKTR-201
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-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106924607700535 [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 Number4
Public Version Date2019-10-23
Device Publish Date2017-09-11

On-Brand Devices [Low-Frequency Therapy Instrument]

06924607700696KTR-206
06924607700603KTR-203
06924607700580KTR-202
06924607700535KTR-201

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.