eVu Senz App

GUDID 07540191000487

Technologie de Pensée Ltée

Psychophysiological biofeedback system
Primary Device ID07540191000487
NIH Device Record Key7cbef97e-ca43-4bd6-8e80-e04253735495
Commercial Distribution StatusIn Commercial Distribution
Brand NameeVu Senz App
Version Model NumberSA4502
Company DUNS209284132
Company NameTechnologie de Pensée Ltée
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
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
GS107540191000487 [Primary]

FDA Product Code

HCCDevice, Biofeedback

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-11-20
Device Publish Date2019-10-29

Devices Manufactured by Technologie de Pensée Ltée

07540191000630 - Resilience – By Inner Armor App iOS2024-04-17
07540191000586 - MyOnyx Mobile App2023-06-15
07540191000593 - MyOnyx 2023-06-15
07540191000623 - eVu Senz App iOS2022-05-16
07540191000609 - Pressure Sensor2022-03-31
07540191000616 - Vaginal Pressure Probe2022-03-31
07540191000555 - MyOnyx2020-07-24
07540191000562 - NEUROINFINITI 22020-07-24

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