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:
ITEM 510(K) NUMBER DATE CLEARED
Myo-trode SG Electrodes K040400 07-20-04
J5 Myomonitor K031998 07-24-03
K7 Evaluation System K003287 11-06-00
EMG Spectral Analysis K992694 09-10-99
ESG Spectral Analysis K970116 04-02-97
Patient Education Software K944134 12-09-94
K6-I Evaluation System K922456 04-15-94
MS-100 EMG Scanner K921919 01-07-93
ESG-1 Electrosonogram K905449/A 04-26-91
J4 Myomonitor K842223 11-19-84
BNS-40 Home Treatment Unit K842224/A 11-19-84
EM-2 Electromyograph K830034 02-09-83
EM-1 Electromyograph K810528 03-31-81
J3 Myomonitor K770252 02-14-77
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