Sensor, Myoscan EMG

GUDID 07540191000227

Technologie de Pensée Ltée

Biofeedback system
Primary Device ID07540191000227
NIH Device Record Key8af81228-1ef1-42bb-ab36-ec5c422e3931
Commercial Distribution StatusIn Commercial Distribution
Brand NameSensor, Myoscan EMG
Version Model NumberSA9503M
Company DUNS209284132
Company NameTechnologie de Pensée Ltée
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 Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107540191000227 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HCCDevice, Biofeedback

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-20
Device Publish Date2017-08-31

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