Is this your brand? Sign in to claim ownership.

Noraxon USA, Inc.

United States·US-MF-000003882

Last updated September 17, 2026

Information

Country: United States
Address: 15770 N. Greenway Hayden Loop., Scottsdale, United States
Website: www.noraxon.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 480 443 3413
PRRC Contact: Alison Fahy
EUDAMED SRN: US-MF-000003882
FDA FEI Number: 2084126
DUNS Number: —

Catalogue (92)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
MyoTrace	042	FDA UDI	Class II	Active
MyoSystem	211	FDA UDI	Class II	Active
Ultium	881	FDA UDI	Class II	Active
TeleMyo	585	FDA UDI	Class II	Unknown
Dual EMG Electrodes	272	FDA UDI	Class II	Active
Dual EMG Wet Gel Ag/AgCl Electrode	272CASE	FDA UDI	Class II	Active
Telemyo	291	FDA UDI	Class II	Active
Telemyo	546	FDA UDI	Class II	Unknown
TeleMyo	587	FDA UDI	Class II	Active
TeleMyo	548	FDA UDI	Class II	Unknown
Telemyo	290	FDA UDI	Class II	Active
Ultium	883	FDA UDI	Class II	Unknown
TeleMyo	584	FDA UDI	Class II	Unknown
TeleMyo	586	FDA UDI	Class II	Unknown
TeleMyo	548	FDA UDI	Class II	Active
TeleMyo	293	FDA UDI	Class II	Unknown
TeleMyo	292	FDA UDI	Class II	Unknown
TeleMyo	580	FDA UDI	Class II	Active
MyoSystem	210	FDA UDI	Class II	Active
TeleMyo	543	FDA UDI	Class II	Unknown
myoRESEARCH - myoMOTION Software Module	405	EUDAMEDFDA UDI	Class I	Active
Ultium EMG Smart Lead (7”)	842X	EUDAMED	Class I	Active
Ultium Accelerometer SmartLead	817	EUDAMED	Class I	Active
Ultium Motion Sensor Strap (XL)	874J	EUDAMED	Class I	Active
Ultium Sensor Charger	873	EUDAMEDFDA UDI	Class I	Active
Ultium EMG Sensor	810	EUDAMEDFDA UDI	Class I	Active
myoMOTION Upper Thoracic Mounting Belt	610E	EUDAMED	Class I	Active
Single Solid Gel Electrode (Pouch of 30)	270S	EUDAMED	Class I	Active
myoMOTION Charging Station	613	EUDAMEDFDA UDI	Class I	Active
Ultium EMG Sports SmartLead	842S	EUDAMED	Class I	Active
NiNOX 120 Camera	144	EUDAMED	Class I	Active
NiNOX 300C Camera	143	EUDAMED	Class I	Active
Solid Gel Dual Electrodes (QTY: 210)	271SCASE	EUDAMEDFDA UDI	Class I	Active
myoMOTION Torso Adapter	610B	EUDAMED	Class I	Active
myoMOTION Strap (XL)	610J	EUDAMED	Class I	Active
myoMOTION Open Sensor Mount Strap (Large)	610Q	EUDAMED	Class I	Active
Ultium Sports Glove (S/M) – Right	874GSR	EUDAMED	Class I	Active
Ultium Footswitch SmartLead	802	EUDAMED	Class I	Active
Myotrace 10 Biofeedback Device	K895633	FDA 510(k)	Class II	Active
Myosystem 1000 Electromyograph	K895635	FDA 510(k)	Class II	Active
Ultium Handgrip Dynamometer SmartLead	829	EUDAMED	Class I	Active
Ultium Insole Sensor (M)	826M	EUDAMED	Class I	Active
myoMOTION Strap (Large)	610L	EUDAMED	Class I	Active
myoRESEARCH (myoFORCE Software Module)	406	EUDAMED	Class I	Active
Core EMG Sensor	816	EUDAMED	Class I	Active
Ultium Insole Sensor (L)	826L	EUDAMED	Class I	Active
Ultium Sports Glove (L/XL) – Right	874GLR	EUDAMED	Class I	Active
Ultium Insole Sensor (XL)	826X	EUDAMED	Class I	Active
Ultium Analog Input SmartLead	811	EUDAMED	Class I	Active
Ultium Sports Glove (L/XL) – Left	874GLL	EUDAMED	Class I	Active

Related Companies

Authorised Representatives

Advena Limited MT

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.