M-Scan
M-Scan records electrical activity from two craniofacial muscles, particularly the temporalis or masseter. It supports clinical assessment and treatment evaluation by comparing muscle…
M-Scan records electrical activity from two craniofacial muscles, particularly the temporalis or masseter. It supports clinical assessment and treatment evaluation by comparing muscle activity within the same patient, either at rest or during a functional action.
The portable electromyographic amplifier processes two channels. Each channel uses differential amplification, buffering, full-wave rectification and integration to produce an integrated display. Fixed bandwidth filtering passes signals from 30 to 1000 Hz, with overall amplification calibrated to 2500.
Listed Item
M-Scan is specifically designed to record craniofacial muscle activity during function and resting.
Self-Contained Operation
A battery powers the unit, which has a built-in digital display and requires no connection to external equipment. The device provides amplification, bandwidth limiting and integration for its displayed muscle-activity signal.
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 | BIO-Research Associates, Inc., United States |
|---|---|
| FDA product code | KZM |
| Device type | Device, Muscle Monitoring |
| Device class | Class 2 |
| Regulation | 21 CFR 890.1375 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K130158 |
| Record published | 2023-06-22 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Rest | In distribution | |
| Clench | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HindexRV | HHS Systems, 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 |
| Monotrode 101 | Myotronics-Noromed, Inc. | 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 |
|---|---|
| K130158 | 2013-07-25 |
| K082927 | 2009-02-06 |
| K003176 | 2001-01-04 |
| K981563 | 1998-09-15 |
| K873947 | 1988-04-27 |
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.