PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE

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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) (5) Stimulator, Electrical, Non-Implantable, For Incontinence (KPI) (4) Perineometer (HIR) (1)

Premarket Exempt

No Yes

Clear

Synergy - 00852423006103 Catalog Number : 9225

Device Description : Synergy® 3-Dimensional Software for the Pathway® MR Series

Device Class : 2

Duns Number: 625863568

Premarket Exempt : Yes

Product Code : HCC

Prescription Use : Yes

Device Count : 1

Pathway - 00852423006110 Catalog Number : NMR400

Device Description : Pathway® NMR 400 Quad Channel EMG System

Device Class : 2

Duns Number: 625863568

Premarket Exempt : No

Product Code : HIR

Prescription Use : No

Device Count : 1

Pathway - 00852423006127 Catalog Number : 8610

Device Description : Pathway® TR-10 Single Channel EMG Trainer

Device Class : 2

Duns Number: 625863568

Premarket Exempt : Yes

Product Code : HCC

Prescription Use : Yes

Device Count : 1

Pathway - 00852423006134 Catalog Number : 8615

Device Description : Pathway® TR-10C Single Channel EMG Trainer

Device Class : 2

Duns Number: 625863568

Premarket Exempt : Yes

Product Code : HCC

Prescription Use : Yes

Device Count : 1

Pathway® - 00852423006141 Catalog Number : 8620

Device Description : Pathway® TR-20 Dual Channel EMG Trainer

Device Class : 2

Duns Number: 625863568

Premarket Exempt : Yes

Product Code : HCC

Prescription Use : Yes

Device Count : 1

Pathway - 00852423006158 Catalog Number : 8625

Device Description : Pathway® TR-20C Dual Channel EMG Trainer

Device Class : 2

Duns Number: 625863568

Premarket Exempt : Yes

Product Code : HCC

Prescription Use : Yes

Device Count : 1

Pathway® - 00852423006165 Catalog Number : STM-10

Device Description : Pathway® STM-10

Device Class : 2

Duns Number: 625863568

Premarket Exempt : No

Product Code : KPI

Prescription Use : Yes

Device Count : 1

Pathway® - 00852423006172 Catalog Number : 6330

Device Description : Pathway® 6330 Vaginal EMG/Stimulation Sensor

Device Class : 2

Duns Number: 625863568

Premarket Exempt : No

Product Code : KPI

Prescription Use : Yes

Device Count : 1

Pathway® - 00852423006189 Catalog Number : 6340

Device Description : Pathway® 6340 Rectal EMG/Stimulation Sensor

Device Class : 2

Duns Number: 625863568

Premarket Exempt : No

Product Code : KPI

Prescription Use : Yes

Device Count : 1

Pathway® - 00852423006196 Catalog Number : 6425

Device Description : Pathway® Rectal Silicon Pressure Sensor

Device Class : 2

Duns Number: 625863568

Premarket Exempt : No

Product Code : KPI

Prescription Use : Yes

Device Count : 1

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