ACCELERATED CARE PLUS CORP

Address:4999 Aircenter Cir.,RENO,NV,89502,US

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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

Electrode, Cutaneous (GXY) (6) Electrode, Electrocardiograph (DRX) (2) Stimulator, Electrical, Non-Implantable, For Incontinence (KPI) (1) Stimulator, Muscle, Powered (IPF) (1)

Premarket Exempt

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Omnistim FX2 Cycle/Walk Portable - 00858703006115 Catalog Number :

Device Description : The OMNISTIM® FX2 CYCLE / WALK provides Patterned Electrical Neuromuscular Stimu The OMNISTIM® FX2 CYCLE / WALK provides Patterned Electrical Neuromuscular Stimulation (PENS), which is a form of stimulation that replicates the correct firing patterns of muscles (agonist and antagonist or reciprocal muscle pairs) in Upper and Lower Extremity reciprocal patterns. This approach to neuro re-ed provides a comfortable, precisely timed sensory input, which duplicates the firing activity of sensory nerves and muscles during voluntary activity.

Device Class : 2

Duns Number: 828331616

Premarket Exempt : No

Product Code : IPF

Prescription Use : Yes

Device Count : 1

Omnistim FX2 Continence Plus Portable - 00858703006122 Catalog Number :

Device Description : Non-implantable electrical stimulator for incontinence

Device Class : 2

Duns Number: 828331616

Premarket Exempt : No

Product Code : KPI

Prescription Use : Yes

Device Count : 1

ACP High Conductivity Electrodes 2X2 - 00858703006153 Catalog Number :

Device Description : TENS Electrodes

Device Class :

Duns Number: 828331616

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

ACP High Conductivity Electrodes 2X4 - 00858703006160 Catalog Number :

Device Description : TENS Electrodes

Device Class :

Duns Number: 828331616

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

ACP High Conductivity Electrodes 3x5 - 00858703006177 Catalog Number :

Device Description : TENS Electrodes

Device Class :

Duns Number: 828331616

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

ACP High Conductivity Electrodes 4x4 electrodes - 00858703006184 Catalog Number :

Device Description : TENS Electrodes

Device Class :

Duns Number: 828331616

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

Synchrony Face & Neck PENS Electrode - 00858703006191 Catalog Number :

Device Description : Cutaneous Electrode

Device Class :

Duns Number: 828331616

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Synchrony Oro-Facial sEMG Electrode - 00858703006207 Catalog Number :

Device Description : Electrocardiograph electrode

Device Class :

Duns Number: 828331616

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

Electrodes Pharyngeal sEMG - 00858703006214 Catalog Number :

Device Description : Electrocardiograph Electrode

Device Class :

Duns Number: 828331616

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

OmniVersa High Conductivity Electrodes - 00858703006238 Catalog Number : 26122

Device Description : 2" x 2" OmniVersa High Conductivity Electrodes

Device Class :

Duns Number: 828331616

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

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