Pressure Sensor

GUDID 07540191000609

Technologie de Pensée Ltée

Psychophysiological biofeedback system
Primary Device ID07540191000609
NIH Device Record Key36957e8a-44a0-4d57-af93-5cff1d1b972a
Commercial Distribution StatusIn Commercial Distribution
Brand NamePressure Sensor
Version Model NumberSA9003
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 Batchtrue
Serial Numberfalse
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
GS107540191000609 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-03-31
Device Publish Date2022-03-23

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
07540191000609 - Pressure Sensor2022-03-31
07540191000616 - Vaginal Pressure Probe2022-03-31
07540191000555 - MyOnyx2020-07-24
07540191000562 - NEUROINFINITI 22020-07-24

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