Technologie de Pensée Ltée

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Device, Biofeedback (HCC) (6) Stimulator, Electrical, Non-Implantable, For Incontinence (KPI) (2) Stimulator, Muscle, Powered (IPF) (2)

Premarket Exempt

No Yes

Clear

MyOnyx Mobile App - 07540191000548 Catalog Number :

Device Class : 2

Duns Number: 209284132

Premarket Exempt : No

Product Code : IPF, KPI, HCC

Prescription Use : Yes

Device Count : 1

MyOnyx - 07540191000555 Catalog Number :

Device Class : 2

Duns Number: 209284132

Premarket Exempt : No

Product Code : HCC, KPI, IPF

Prescription Use : No

Device Count : 1

NEUROINFINITI 2 - 07540191000562 Catalog Number :

Device Class : 2

Duns Number: 209284132

Premarket Exempt : No

Product Code : HCC

Prescription Use : No

Device Count : 1

Pressure Sensor - 07540191000609 Catalog Number :

Device Class : 2

Duns Number: 209284132

Premarket Exempt : No

Product Code : HCC

Prescription Use : No

Device Count : 1

Vaginal Pressure Probe - 07540191000616 Catalog Number :

Device Class : 2

Duns Number: 209284132

Premarket Exempt : No

Product Code : HCC

Prescription Use : No

Device Count : 1

eVu Senz App iOS - 07540191000623 Catalog Number :

Device Class : 2

Duns Number: 209284132

Premarket Exempt : Yes

Product Code : HCC

Prescription Use : Yes

Device Count : 1

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