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:
| 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 | 01-19-84 |
| 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 |
| Norotrack 360 | K920690 | 05-20-92 |
| Norodyn 2000 | K922838A | 09-02-94 |
| Norodyn 8000 (Physiotech 4000) | K922270 | 09-02-94 |
| Norodyn 888 (Spectral Analysis) | K992439 | 08-13-99 |
| MES-9000/Norotrack 360 System | K013357 | 11-08-01 |
| MES-9000/EMG System | K013399 | 11-13-01 |
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)
Canadian Device License #111544 (K7)
Registered to ISO-13485: 2016 MDSAP
