Noraxon U.S.A., Inc.

Address:15770 N Greenway Hayden Loop,SCOTTSDALE,AZ,85260,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, Biofeedback (HCC) (6) Goniometer, Ac-Powered (KQX) (4)

Premarket Exempt

Yes

Clear

TeleMyo - 00816271020148 Catalog Number :

Device Description : Telemyo Mini Receiver

Device Class : 2

Duns Number: 611243809

Premarket Exempt : Yes

Product Code : HCC

Prescription Use : No

Device Count : 1

TeleMyo - 00816271020155 Catalog Number :

Device Description : Telemyo DTS Desktop Receiver (W/O Analog Out)

Device Class : 2

Duns Number: 611243809

Premarket Exempt : Yes

Product Code : HCC

Prescription Use : No

Device Count : 1

Ultium - 00816271020216 Catalog Number :

Device Description : Ultium EMG Receiver

Device Class : 2

Duns Number: 611243809

Premarket Exempt : Yes

Product Code : HCC

Prescription Use : No

Device Count : 1

Ultium - 00816271020223 Catalog Number :

Device Description : Ultium EMG Sensor

Device Class : 2

Duns Number: 611243809

Premarket Exempt : Yes

Product Code : HCC

Prescription Use : No

Device Count : 1

Ultium - 00816271020230 Catalog Number :

Device Description : Ultium EMG Sensor Charging Station

Device Class : 2

Duns Number: 611243809

Premarket Exempt : Yes

Product Code : HCC

Prescription Use : No

Device Count : 1

MyoMotion - 00816271020247 Catalog Number :

Device Description : Research Sensor

Device Class : 1

Duns Number: 611243809

Premarket Exempt : Yes

Product Code : KQX

Prescription Use : No

Device Count : 1

MyoMotion - 00816271020254 Catalog Number :

Device Description : MyoMotion Research Pro Receiver

Device Class : 1

Duns Number: 611243809

Premarket Exempt : Yes

Product Code : KQX

Prescription Use : No

Device Count : 1

MyoMotion - 00816271020261 Catalog Number :

Device Description : MyoMotion Sensor Charging Station

Device Class : 1

Duns Number: 611243809

Premarket Exempt : Yes

Product Code : KQX

Prescription Use : No

Device Count : 1

Ultium - 00816271020278 Catalog Number :

Device Description : Ultium Analog Output

Device Class : 2

Duns Number: 611243809

Premarket Exempt : Yes

Product Code : HCC

Prescription Use : No

Device Count : 1

MyoMotion - 00816271020285 Catalog Number :

Device Description : Clinical Sensor

Device Class : 1

Duns Number: 611243809

Premarket Exempt : Yes

Product Code : KQX

Prescription Use : No

Device Count : 1

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