Myotrac Infiniti Encoder

GUDID 07540191000104

Technologie de Pensée Ltée

Physical therapy transcutaneous neuromuscular electrical stimulation system
Primary Device ID07540191000104
NIH Device Record Key568fdae2-122b-47e3-8be5-abf46d281a76
Commercial Distribution StatusIn Commercial Distribution
Brand NameMyotrac Infiniti Encoder
Version Model NumberSA9800
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
GS107540191000104 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IPFStimulator, Muscle, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-11-20
Device Publish Date2017-08-31

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