Noraxon U.S.A., Inc.

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) (9) Goniometer, Ac-Powered (KQX) (1)

Premarket Exempt

Yes

Clear

Ultium - 00816271020001 Catalog Number :

Device Description : Ultium Sensor Charger

Device Class : 1

Duns Number: 611243809

Premarket Exempt : Yes

Product Code : KQX

Prescription Use : No

Device Count : 1

TeleMyo - 00816271020049 Catalog Number :

Device Description : Telemyo 2400T G2

Device Class : 2

Duns Number: 611243809

Premarket Exempt : Yes

Product Code : HCC

Prescription Use : No

Device Count : 1

TeleMyo - 00816271020056 Catalog Number :

Device Description : Telemyo PC-Interface

Device Class : 2

Duns Number: 611243809

Premarket Exempt : Yes

Product Code : HCC

Prescription Use : No

Device Count : 1

TeleMyo - 00816271020063 Catalog Number :

Device Description : TeleMyo Sensor Charger

Device Class : 2

Duns Number: 611243809

Premarket Exempt : Yes

Product Code : HCC

Prescription Use : No

Device Count : 1

TeleMyo - 00816271020087 Catalog Number :

Device Description : Telemyo DTS EMG

Device Class : 2

Duns Number: 611243809

Premarket Exempt : Yes

Product Code : HCC

Prescription Use : No

Device Count : 1

Telemyo - 00816271020094 Catalog Number :

Device Description : Telemyo Clinical DTS EMG

Device Class : 2

Duns Number: 611243809

Premarket Exempt : Yes

Product Code : HCC

Prescription Use : No

Device Count : 1

TeleMyo - 00816271020100 Catalog Number :

Device Description : Telemyo Research DTS EMG Lossless

Device Class : 2

Duns Number: 611243809

Premarket Exempt : Yes

Product Code : HCC

Prescription Use : No

Device Count : 1

TeleMyo - 00816271020117 Catalog Number :

Device Description : Telemyo DTS Belt Receiver

Device Class : 2

Duns Number: 611243809

Premarket Exempt : Yes

Product Code : HCC

Prescription Use : No

Device Count : 1

TeleMyo - 00816271020124 Catalog Number :

Device Description : Telemyo DTS Desktop Receiver

Device Class : 2

Duns Number: 611243809

Premarket Exempt : Yes

Product Code : HCC

Prescription Use : No

Device Count : 1

TeleMyo - 00816271020131 Catalog Number :

Device Description : Telemyo Clinical DTS Receiver

Device Class : 2

Duns Number: 611243809

Premarket Exempt : Yes

Product Code : HCC

Prescription Use : No

Device Count : 1

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