INNOVATIVE NEUROTRONICS, INC.

Address:4999 AIRCENTER CIR STE 103,Reno,NV,89502,US

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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, Neuromuscular, External Functional (GZI) (7) Electrode, Cutaneous (GXY) (3)

Premarket Exempt

Clear

WalkAide Unit - 00858184006000 Catalog Number :

Device Description : The WalkAide is a battery-operated, single channel electricalstimulator that is

Device Class : 2

Duns Number: 791468734

Premarket Exempt : No

Product Code : GZI

Prescription Use : Yes

Device Count : 1

WalkAide Kit - 00858184006017 Catalog Number :

Device Description : The WalkAide is a battery-operated, single channel electricalstimulator that is

Device Class : 2

Duns Number: 791468734

Premarket Exempt : No

Product Code : GZI

Prescription Use : Yes

Device Count : 1

WalkAide Kit for Japan - 00858184006031 Catalog Number :

Device Description : The WalkAide is a battery-operated, single channel electricalstimulator that is

Device Class : 2

Duns Number: 791468734

Premarket Exempt : No

Product Code : GZI

Prescription Use : Yes

Device Count : 1

WalkAide Kit for Demo Use - 00858184006048 Catalog Number :

Device Description : The WalkAide is a battery-operated, single channel electricalstimulator that is

Device Class : 2

Duns Number: 791468734

Premarket Exempt : No

Product Code : GZI

Prescription Use : Yes

Device Count : 1

WalkLink Unit - 00858184006055 Catalog Number :

Device Description : Provides a wireless connection between the WalkAide and a computer, and also all

Device Class : 2

Duns Number: 791468734

Premarket Exempt : No

Product Code : GZI

Prescription Use : Yes

Device Count : 1

WalkLink System ((Clinician Kit) - 00858184006062 Catalog Number :

Device Description : Provides a wireless connection between the WalkAide and a computer, and also all

Device Class : 2

Duns Number: 791468734

Premarket Exempt : No

Product Code : GZI

Prescription Use : Yes

Device Count : 1

WalkAide Electrodes - package of 4 - 00858184006079 Catalog Number :

Device Description : Transcutaneous Electrical Stimulation Electrode

Device Class :

Duns Number: 791468734

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

WalkAide 1.25 Premium Electrodes - pkg of 4 - 00858184006109 Catalog Number :

Device Description : Transcutaneous Electrical Stimulation Electrode

Device Class :

Duns Number: 791468734

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

WalkAide 1.875 Premium Electrodes - pkg of 4 - 00858184006123 Catalog Number :

Device Description : Transcutaneous Electrical Stimulation Electrode

Device Class :

Duns Number: 791468734

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

WalkAnalyst Software Kit - 00858184006130 Catalog Number :

Device Description : Software used by the clinician to interface with the WalkAide unit. This allows

Device Class : 2

Duns Number: 791468734

Premarket Exempt : No

Product Code : GZI

Prescription Use : Yes

Device Count : 1

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