Powered Muscle Stimulator

GUDID 06924607701273

Shenzhen Kentro Medical Electronics Co.,Ltd

Physical therapy transcutaneous neuromuscular electrical stimulation system
Primary Device ID06924607701273
NIH Device Record Key26193664-fcfa-4c6d-8475-25be8c1c69ab
Commercial Distribution StatusIn Commercial Distribution
Brand NamePowered Muscle Stimulator
Version Model NumberKTR-233
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS106924607701273 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NGXStimulator, Muscle, Powered, For Muscle Conditioning

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-10-23
Device Publish Date2019-01-11

On-Brand Devices [Powered Muscle Stimulator]

06924607701280KTR-234
06924607701273KTR-233
06924607701266KTR-232
06924607701259KTR-231
06924607701242KTR-230B
06924607701235KTR-230P
06924607701228KTR-230W

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