
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
