Noraxon Usa Inc

FDA Filings

This page includes the latest FDA filings for Noraxon Usa Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 2084126
• FEI Number: 2084126
• Name: NORAXON USA, INC.
• Owner & Operator: NORAXON USA, INC.
• Contact Address: 15770 North Greenway-Hayden Loop Suite 100; Scottsdale AZ 85260 US
• Official Correspondent:
  • Estefania Meza
  • x-480-4433413-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 15770 N Greenway Hayden Loop No. 100; SCOTTSDALE, AZ 85260 US
• Establishment Type:
  • Manufacture Medical Device
  • Repack or Relabel Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
KQW NORAXON USA, INC.	MyoVideo	2013-11-08
KQX NORAXON USA, INC.	MyoMotion	2012-07-24
IKE NORAXON USA, INC.	forZe	2012-07-24
IKE NORAXON USA, INC.	PhysTread	2012-07-24
IKE NORAXON USA, INC.	MyoPressure	2012-07-24
IKE NORAXON USA, INC.	KinTread	2012-07-24
IKE NORAXON USA, INC.	GaiTread	2012-07-24
HCC NORAXON USA, INC.	Ultium EMG System	1998-02-19
HCC NORAXON USA, INC.	TeleMyo Mini DTS	1998-02-19
HCC NORAXON USA, INC.	TeleMyo Desktop DTS	1998-02-19
HCC NORAXON USA, INC.	TeleMyo DTS	1998-02-19
HCC NORAXON USA, INC.	TeleMyo Clinical DTS	1998-02-19
HCC NORAXON USA, INC.	TeleMyo 2400 G2	1998-02-19
HCC NORAXON USA, INC.	MyoTrace 400	1998-02-19
HCC NORAXON USA, INC.	MyoSystem 1400A/L	1998-02-19
PMN K895635 NORAXON USA, INC.	MYOSYSTEM 1000 ELECTROMYOGRAPH	1990-04-19
PMN K895633 NORAXON USA, INC.	MYOTRACE 10 BIOFEEDBACK DEVICE	1990-04-13