All Noromed 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 |
Norotrack 360 |
K920690 | 05-20-92 |
Norodyn 2000 |
K922838A | 09-02-94 |
Norodyn 8000 (Physiotech 4000) |
K922270 |
09-02-94 |
Norodyn 8000 (Spectral Analysis) |
K992439 |
08-13-99 |
MES-9000/Norotrack 360 System |
K013357 |
11-08-01 |
MES-9000/EMG System |
K013399 |
11-13-01 |
Since 1998
Myotronics-Noromed's Quality Systems have been continually audited and approved
by independent auditors authorized by National Accreditation Bodies. All major
products meet the additional safety and efficacy requirements of that organization which permit
affixing the "CE" mark.
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 insure 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.