Rehabtronics Inc

Address:#4350, 10230 - Jasper Avenue,Edmonton Alberta,CA

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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

Stimulator, Muscle, Powered (IPF) (7) Stimulator, Neuromuscular, External Functional (GZI) (3)

Premarket Exempt

No Yes

Clear

ReGrasp - 17540176030116 Catalog Number :

Device Description : ReGrasp Base System

Device Class : 2

Duns Number: 243936569

Premarket Exempt : No

Product Code : GZI, IPF

Prescription Use : Yes

Device Count : 1

ReGrasp - 17540176030123 Catalog Number :

Device Description : ReGrasp Electrode Positioning Kit

Device Class : 2

Duns Number: 243936569

Premarket Exempt : No

Product Code : GZI, IPF

Prescription Use : Yes

Device Count : 1

ReGrasp - 17540176030130 Catalog Number :

Device Description : ReGrasp Electrode Positioning Kit Refill

Device Class : 2

Duns Number: 243936569

Premarket Exempt : No

Product Code : GZI, IPF

Prescription Use : Yes

Device Count : 1

Prelivia - 17540176050008 Catalog Number :

Device Description : The Prelivia System is a portable transcutaneous muscle stimulation system inten The Prelivia System is a portable transcutaneous muscle stimulation system intended to increase regional blood circulation at stimulated treatment areas, and to reduce the incidence and progression of pressure ulcers (bed sores) in individuals who are immobile due to their clinical condition. The system consists of a battery

Device Class : 2

Duns Number: 243936569

Premarket Exempt : No

Product Code : IPF

Prescription Use : No

Device Count : 1

Prelivia Electrodes - 17540176050022 Catalog Number : PR-IES1

Device Class : 2

Duns Number: 243936569

Premarket Exempt : No

Product Code : IPF

Prescription Use : No

Device Count : 1

Prelivia Leads - 17540176050039 Catalog Number : PR-LEAD1

Device Description : Leads for Prelivia

Device Class : 2

Duns Number: 243936569

Premarket Exempt : No

Product Code : IPF

Prescription Use : No

Device Count : 1

Prelivia Lead Bulk - 17540176050046 Catalog Number : PR-LEAD1B

Device Description : Pack of 10 Leads

Device Class : 2

Duns Number: 243936569

Premarket Exempt : No

Product Code : IPF

Prescription Use : No

Device Count : 1

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