AVAZZIA INC

Address:13140 Coit Rd Ste 515,DALLAS,TX,75240,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, Nerve, Transcutaneous, For Pain Relief (GZJ) (4) Stimulator, Nerve, Transcutaneous, Over-The-Counter (NUH) (4)

Premarket Exempt

No Yes

Clear

Avazzia - 00851530007706 Catalog Number : A4-MS-K-Y-OTC

Device Description : Convenience kit with Med Sport OTC device, conductive pads, Y electrode, lead wi Convenience kit with Med Sport OTC device, conductive pads, Y electrode, lead wires, and carry case.

Device Class : 2

Duns Number: 603638607

Premarket Exempt : No

Product Code : NUH

Prescription Use : No

Device Count : 1

Avazzia - 00851530007720 Catalog Number : A4-AE

Device Description : Avazzia Life Evolution device

Device Class : 2

Duns Number: 603638607

Premarket Exempt : No

Product Code : GZJ

Prescription Use : Yes

Device Count : 1

Avazzia - 00851530007737 Catalog Number : A4-AE-K-Y

Device Description : Convenience kit with Avazzia Life Evolution device, conductive pads, Y electrode Convenience kit with Avazzia Life Evolution device, conductive pads, Y electrode, lead wires, and carry case.

Device Class : 2

Duns Number: 603638607

Premarket Exempt : No

Product Code : GZJ

Prescription Use : Yes

Device Count : 1

Avazzia - 00851530007744 Catalog Number : A4-AG OTC

Device Description : Avazzia Life Genesis, OTC

Device Class : 2

Duns Number: 603638607

Premarket Exempt : No

Product Code : NUH

Prescription Use : No

Device Count : 1

Avazzia - 00851530007751 Catalog Number : A4-AG-K-Y OTC

Device Description : Convenience kit with Avazzia Life Genesis OTC device, conductive pads, Y electro Convenience kit with Avazzia Life Genesis OTC device, conductive pads, Y electrode, lead wires, and carry case.

Device Class : 2

Duns Number: 603638607

Premarket Exempt : No

Product Code : NUH

Prescription Use : No

Device Count : 1

Avazzia - 00851530007768 Catalog Number : A4-AG-K OTC

Device Description : Convenience kit with Avazzia Life Genesis OTC device, conductive pads, lead wire Convenience kit with Avazzia Life Genesis OTC device, conductive pads, lead wire, and pouch.

Device Class : 2

Duns Number: 603638607

Premarket Exempt : No

Product Code : NUH

Prescription Use : No

Device Count : 1

Avazzia - 00851530007775 Catalog Number : A4-AP

Device Description : Avazzia Life Pinnacle device with batteries and instruction manual.

Device Class : 2

Duns Number: 603638607

Premarket Exempt : No

Product Code : GZJ

Prescription Use : Yes

Device Count : 1

Avazzia - 00851530007782 Catalog Number : A4-AP-K

Device Description : Convenience kit with Avazzia Life Pinnacle device, conductive pads, Y electrode Convenience kit with Avazzia Life Pinnacle device, conductive pads, Y electrode accessory, brush electrode accessory, lead wires, batteries, instruction manual and carry case.

Device Class : 2

Duns Number: 603638607

Premarket Exempt : No

Product Code : GZJ

Prescription Use : Yes

Device Count : 1

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