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 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  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 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)
Registered to ISO-13485: 2016 MDSAP

Address:

5870 S. 194th Street

Kent, WA 98032-2125

Phone:

(206)243-4214 or (800)426-0316

Email:

info@myotronics.com

Fax:

(206)243-3625

A Division of Myotronics-Noromed, Inc.
Leading in Musculoskeletal Evaluation Technologies Since 1966

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