Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2084126

FEI Number

2084126

Entity Name

NORAXON USA, INC.

City/State/Country

SCOTTSDALE, AZ, US

Establishment Address

15770 N Greenway Hayden Loop, No. 100, SCOTTSDALE, AZ 85260, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

NORAXON USA, INC. (Owner Number: 2084126)

Owner / Operator Contact Address

15770 North Greenway-Hayden Loop, Suite 100, Scottsdale, AZ 85260, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Ultium Motion MyoMotion PhysTread GaiTread KinTread forZe MyoPressure MyoVideo MyoTrace 400 TeleMyo 2400 G2 MyoSystem 1400A/L TeleMyo Clinical DTS TeleMyo Desktop DTS TeleMyo Mini DTS Ultium EMG System TeleMyo DTS Dual EMG Ag/AgCl Electrodes myoMUSCLE Core EMG System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KQX	Goniometer, Ac-Powered	Orthopedic	Class 1	888.1500	2012-07-24
IKE	Transducer, Miniature Pressure	Physical Medicine	Class 1	890.1615	2012-07-24
KQW	Goniometer, Nonpowered	Orthopedic	Class 1	888.1520	2013-11-08
HCC	Device, Biofeedback	Neurology	Class 2	882.5050	1998-02-19

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

NORAXON USA, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K873418	Bodylog, Inc.	BODYLOG STRESS REDUCTION PACKAGE	1987-12-17
K792659	Bio-Feedback Systems, Inc.	FEEDBACK EDR SYSTEM MODEL ME-1	1980-01-09

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2084126. Last updated year: 2026. Please use registration number 2084126 when referencing this establishment in official correspondence.