| Primary Device ID | 00860003499900 |
| NIH Device Record Key | 0d6a683f-add5-47a3-866b-945c1231a140 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BioEMG |
| Version Model Number | III NRG V2 |
| Company DUNS | 063501373 |
| Company Name | Bio-Research Associates, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| 00860009598201 - Taylor Industries | 2023-08-25 |
| 00860003499900 - BioEMG | 2023-06-30Indications 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. |
| 00860003499900 - BioEMG | 2023-06-30 Indications for use: 8 channel EMG Amplifier
1. To record electrical activity of muscles of the stomatognathic system, especiall |
| 00860003499917 - JT-3D | 2023-06-30 The Jaw Tracker-3D is a non-invasive, non-painful test that records incisor-point movements in three dimensions. A small magnet, |
| 00860003499924 - BioJVA | 2023-06-30 Indications for use: 2 channel JVA amplifier
1. To record and display sounds/vibrations from the temporomandibular joints.
2. To |
| 00860003499931 - BioJVA | 2023-06-30 |
| 00860003499948 - BioPAK | 2023-06-30 |
| 00860003499955 - M-Scan | 2023-06-30 M-Scan is specifically designed to record craniofacial muscle activity during function and resting. |
| 00860003499962 - M-Scan | 2023-06-30 M-Scan is specifically designed to record craniofacial muscle activity during function and resting. |