These certifications provide the customer with assurance of safe, effective products of the highest quality.

FDA Information

All Myotronics devices are registered with the U.S. Food and Drug Administration and have received permission for marketing under 510(k) pre-market notifications.

Dates and FDA document control numbers for all instruments are listed below:

ITEM501(K) NumberDATE CLEARED
Myo-trode SG ElectrodesK04040007-20-04
J5 MyomonitorK03199807-24-03
K7 Evaluation SystemK00328711-06-00
EMG Spectral AnalysisK99269409-10-99
ESG Spectral AnalysisK97011604-02-97
Patient Education SoftwareK94413412-09-94
K6-I Evaluation SystemK92245604-15-94
MS-100 EMG ScannerK92191901-07-93
ESG-1 ElectrosonogramK905449/A04-26-91
J4 MyomonitorK84222301-19-84
BNS-40 Home Treatment UnitK842224/A11-19-84
EM-2 ElectromyographK83003402-09-83
EM-1 ElectromyographK81052803-31-81
J3 MyomonitorK77025202-14-77
Norotrack 360K92069005-20-92
Norodyn 2000K922838A09-02-94
Norodyn 8000 (Physiotech 4000)K92227009-02-94
Norodyn 888 (Spectral Analysis)K99243908-13-99
MES-9000/Norotrack 360 SystemK01335711-08-01
MES-9000/EMG SystemK01339911-13-01

ISO Information

Since 1998 Myotronics-Noromed’s Quality Systems have been continually audited and approved by independent auditors authorized by National Accreditation Bodies. The Company is currently certified to ISO-13485. All major products meet the additional safety and efficacy requirements of that organization which permit affixing the “CE” mark to the products.

Quality Policy

Myotronics-Noromed, Inc. is committed to manufacturing quality products, backed by strong service support, that satisfy customer requirements. Products are designed and manufactured to meet current legal and regulatory standards. To ensure a high level of customer satisfaction, the Company maintains a quality system designed to actively monitor and continually improve its products, services and the quality system itself.

Canadian Credentials

Medical Device Establishment License #3429
Canadian Device License # 3070 (J4/J5/BNS-40)
Registered to ISO-13485: 2016 MDSAP

ISO 13485_2016 black TM