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:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

ITEM

501(K) NUMBER

DATE CLEARED

Myo-trode SG Electrodes

J5 Myomonitor

K7 Evaluation System

EMG Spectral Analysis 

ESG Spectral Analysis

Patient Education Software

K6-I Evaluation System

MS-100 EMG Scanner

ESG-1 Electrosonogram

J4 Myomonitor

BNS-40 Home Treatment Unit  

EM-2 Electromyograph

EM-1 Electromyograph

J3 Myomonitor

Norotrack 360

Norodyn 2000

Norodyn 8000 (Physiotech 4000)

Norodyn 888 (Spectral Analysis)

MES-9000/Norotrack 360 System

MES-9000/EMG System

K040400

K031998 

 K003287 

 K992694 

K970116

  K944134  

K922456

K921919 

K905449/A 

K842223

K842224/A

K830034 

K810528

K770252 

K920690

K922838A

K922270

K992439

K013357

K013399

07-20-04

07-24-03

11-06-00

09-10-99

04-02-97

12-09-94

 04-15-94

01-07-93

04-26-91

01-19-84

11-19-84

 02-09-83

03-31-81

02-14-77

05-20-92

09-02-94

 09-02-94

08-13-99

11-08-01

11-13-01

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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