NEUROMETRIX, INC.

Address:4-B Gill Street,Woburn,MA,01801,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

Device, Nerve Conduction Velocity Measurement (JXE) (4) Electrode, Cutaneous (GXY) (3) Stimulator, Nerve, Transcutaneous, Over-The-Counter (NUH) (3)

Premarket Exempt

Clear

QUELL - 00851221006001 Catalog Number :

Device Description : Consumer Starter Kit (includes device, 1 pack electrode with UDI 00851221006018, Consumer Starter Kit (includes device, 1 pack electrode with UDI 00851221006018, 1 charger, 1 charger cable, 1 sport band)

Device Class : 2

Duns Number: 957536014

Premarket Exempt : No

Product Code : NUH

Prescription Use : No

Device Count : 1

QUELL - 00851221006018 Catalog Number :

Device Description : QUELL Electrode

Device Class : 2

Duns Number: 957536014

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

QUELL - 00851221006025 Catalog Number :

Device Description : Retailer Quell Device Box (includes device, 1 electrode with UDI 00851221006018 Retailer Quell Device Box (includes device, 1 electrode with UDI 00851221006018 or UDI 00851221006049, 1 charger, 1 charger cable, 1 sport band)

Device Class :

Duns Number: 957536014

Premarket Exempt : No

Product Code : NUH

Prescription Use : No

Device Count : 1

QUELL - 00851221006032 Catalog Number :

Device Description : Quell Electrodes Retail - 1 Month supply (1 pack electrodes with UDI 00851221006 Quell Electrodes Retail - 1 Month supply (1 pack electrodes with UDI 00851221006018 or UDI 00851221006049 in shipping box)

Device Class : 2

Duns Number: 957536014

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

QUELL - 00851221006049 Catalog Number :

Device Description : QUELL Sport Electrode

Device Class : 2

Duns Number: 957536014

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

QUELL - 00851221006070 Catalog Number :

Device Description : HCP Starter Kit (includes device, 1 pack electrode with UDI 00851221006018, 1 ch HCP Starter Kit (includes device, 1 pack electrode with UDI 00851221006018, 1 charger, 1 charger cable, 1 sport band)

Device Class : 2

Duns Number: 957536014

Premarket Exempt : No

Product Code : NUH

Prescription Use : No

Device Count : 1

NC-stat DPNCheck - 00851221006087 Catalog Number : DB-025, DB-050

Device Description : NC-stat DPNCheck BiosensorDB-025 = QTY 25 OF NC-DP2DB-050 = QTY 50 OF NC-DP2

Device Class :

Duns Number: 957536014

Premarket Exempt : No

Product Code : JXE

Prescription Use : Yes

Device Count : 1

ADVANCE - 00851221006094 Catalog Number :

Device Description : Peroneal Biosensor (Right) Individual

Device Class :

Duns Number: 957536014

Premarket Exempt : No

Product Code : JXE

Prescription Use : Yes

Device Count : 1

ADVANCE - 00851221006100 Catalog Number :

Device Description : Peroneal Biosensor (Left) Individual

Device Class : 2

Duns Number: 957536014

Premarket Exempt : No

Product Code : JXE

Prescription Use : Yes

Device Count : 1

ADVANCE - 00851221006117 Catalog Number :

Device Description : Superficial Peroneal Biosensor (Right) Individual

Device Class : 2

Duns Number: 957536014

Premarket Exempt : No

Product Code : JXE

Prescription Use : Yes

Device Count : 1

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