Monotrode 101
High quality disposable (single use) electrodes for surface electromyography (EMG).
1manufacturer
1catalogue number
2510(k) clearances naming this product code
Who Else Makes It
Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangyin Sinbon Electronics Co Ltd | Jiangyin | Jiangsu | Contract manufacturer | 13 |
Record
| Listed by | Myotronics-Noromed, Inc., United States |
|---|---|
| FDA product code | KZM |
| Device type | Device, Muscle Monitoring |
| Device class | Class 2 |
| Regulation | 21 CFR 890.1375 |
| Establishment | Repacker / relabeller, Manufacturer |
| Record published | 2016-09-19 |
| Record revised | 2023-12-18 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 101 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HindexRV | HHS Systems, Inc. | 2 |
| M-Scan | BIO-Research Associates, Inc. | 2 |
| MES 9000 Dynamic EMG | Myotronics-Noromed, Inc. | 1 |
| BioPAK | BIO-Research Associates, Inc. | 1 |
| K7 Evaluation System-EMG | Myotronics-Noromed, Inc. | 1 |
| Nox A1 Starter Sensor Kit, Pediatric | Nox Medical Ehf | 1 |
| Teethan | BTS SPA | 1 |
| Nox A1 Carry Case | Nox Medical Ehf | 1 |
| BioEMG | BIO-Research Associates, Inc. | 1 |
| MES 9000 Musculoskeletal System | Myotronics-Noromed, Inc. | 1 |
| K7 EMG Electromyograph | Myotronics-Noromed, Inc. | 1 |
| K7 Evaluation System-ESG | Myotronics-Noromed, Inc. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K003287 | 2000-11-06 |
| K992694 | 1999-09-10 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.