Model Mes-9000/Emg System
510(k) K013399
Model Mes-9000/Emg System is a medical device (FDA Class II; FDA product code HCC, Device, Biofeedback) made by Myotronics-Noromed, Inc., cleared under FDA 510(k) K013399 on 13 Nov 2001, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK013399 | Date13 Nov 2001 | StatusActive |
Official records
- FDA 510(k) database K013399
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HCC
- Device class
- Class II
- Regulation
- 21 CFR Part 882.5050
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K013399
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| MES 9000 Dynamic EMG MES 9000 EMG | MES 9000 EMG | D792N9200A0 | On the market | |
| MES 9000 Muscle Tester | Muscle Tester | D792N9600A0 | On the market | |
| MES 9000 Musculoskeletal System N9000M | N9000M | D792N9000M0 | On the market | |
| MES 9000 Static Electromyography Scanner Static EMG Scanner | Static EMG Scanner | D792N150MES0 | On the market | |
| Norotrode 20 N120 | N120 | D792N12011 | On the market |
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