Certifications

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 Anaysis	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

ISO INFORMATION

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 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 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.

CANADIAN CREDENTIALS

Medical Device Establishment License #1353

Canadian Device License # 3070 (J4/J5/BNS-40)

Registered to ISO-13485: 2003CMDCAS