Certifications

Myotronics-Noromed, Inc. manufacturers FDA registration number: 3014732

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

ISO INFORMATION

ISO Symbol Since 1998 Myotronics-Noromed's Quality Systems have been continually audited and approved by independent auditors authorized by the International Standards Organization (ISO). All major products meet the additional safety and efficacy requirements of that organization which permit affixing the "CE" mark.

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 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.