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

Item

ISO INFORMATION

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.

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.