Indications for use: 8 channel EMG Amplifier 1. To record electrical activity of muscles of the stomatognathic system, especially temporalis, masseter and digastric. 2. To clinically…
Indications for use: 8 channel EMG Amplifier 1. To record electrical activity of muscles of the stomatognathic system, especially temporalis, masseter and digastric. 2. To clinically monitor up to eight different muscles as an aid in the diagnosis and treatments evaluation by recording the electrical activity of muscles of the stomatognathic system. 3. To determine the degree of relaxation (intra-patient) of a single muscle/group of muscles at rest. 4. To measure relative (intra-patient) levels of activity of several muscles during a functional act. Indications for use: 2 channel JVA amplifier 1. To record and display sounds/vibrations from the temporomandibular joints. 2. To aid the clinician in their analysis of a joint sound/vibration by allowing them to see the waveform in various standard plots. 3. To aid the clinician in comparing a patient’s current stand plots to previous recordings before, during, and after treatment. 4. To provide numerical values that can be used to quantify the physical characteristics of the sounds/vibrations, allowing intra-patient comparisons (only) by the clinician.
Who Else Makes It
Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for BioEMG | 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) | K082927 |
| Record published | 2023-06-22 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Label carries | lot or batch number, manufacturing date, serial number |
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.