These certifications provide the customer with assurance of safe, effective products of the highest quality.
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:
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.
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.
Medical Device Establishment License #3429
Canadian Device License # 3070 (J4/J5/BNS-40)
Registered to ISO-13485: 2016 MDSAP
Myo-trode SG Electrodes
K7 Evaluation System
EMG Spectral Analysis
ESG Spectral Analysis
Patient Education Software
K6-I Evaluation System
MS-100 EMG Scanner
BNS-40 Home Treatment Unit
Norodyn 8000 (Physiotech 4000)
Norodyn 888 (Spectral Analysis)
MES-9000/Norotrack 360 System