| Primary Device ID | 00860003499979 |
| NIH Device Record Key | 9f0a0c3a-0758-436e-a0a6-eff7c499d17e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | QuadraTENS |
| Version Model Number | Unit |
| 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 |
| Phone | 4143577525 |
| info@bioresearchinc.com | |
| Phone | 4143577525 |
| info@bioresearchinc.com | |
| Phone | 4143577525 |
| info@bioresearchinc.com | |
| Phone | 4143577525 |
| info@bioresearchinc.com | |
| Phone | 4143577525 |
| info@bioresearchinc.com | |
| Phone | 4143577525 |
| info@bioresearchinc.com | |
| Phone | 4143577525 |
| info@bioresearchinc.com | |
| Phone | 4143577525 |
| info@bioresearchinc.com | |
| Phone | 4143577525 |
| info@bioresearchinc.com | |
| Phone | 4143577525 |
| info@bioresearchinc.com | |
| Phone | 4143577525 |
| info@bioresearchinc.com | |
| Phone | 4143577525 |
| info@bioresearchinc.com | |
| Phone | 4143577525 |
| info@bioresearchinc.com | |
| Phone | 4143577525 |
| info@bioresearchinc.com | |
| Phone | 4143577525 |
| info@bioresearchinc.com | |
| Phone | 4143577525 |
| info@bioresearchinc.com | |
| Phone | 4143577525 |
| info@bioresearchinc.com | |
| Phone | 4143577525 |
| info@bioresearchinc.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860003499979 [Primary] |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-30 |
| Device Publish Date | 2023-06-22 |
| 00860009598201 - Taylor Industries | 2023-08-25 |
| 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. |