| Primary Device ID | D79240602 |
| NIH Device Record Key | a6c66e46-e5a6-4299-8740-8d15c0d55718 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Myotrode One With Gel |
| Version Model Number | 4060 |
| Company DUNS | 053824652 |
| Company Name | MYOTRONICS NOROMED, 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 2062434214 |
| info@myotronics.com | |
| Phone | 2062434214 |
| info@myotronics.com | |
| Phone | 2062434214 |
| info@myotronics.com | |
| Phone | 2062434214 |
| info@myotronics.com | |
| Phone | 2062434214 |
| info@myotronics.com | |
| Phone | 2062434214 |
| info@myotronics.com | |
| Phone | 2062434214 |
| info@myotronics.com | |
| Phone | 2062434214 |
| info@myotronics.com | |
| Phone | 2062434214 |
| info@myotronics.com | |
| Phone | 2062434214 |
| info@myotronics.com | |
| Phone | 2062434214 |
| info@myotronics.com | |
| Phone | 2062434214 |
| info@myotronics.com | |
| Phone | 2062434214 |
| info@myotronics.com | |
| Phone | 2062434214 |
| info@myotronics.com | |
| Phone | 2062434214 |
| info@myotronics.com | |
| Phone | 2062434214 |
| info@myotronics.com | |
| Phone | 2062434214 |
| info@myotronics.com | |
| Phone | 2062434214 |
| info@myotronics.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D79240602 [Primary] |
| NUW | Stimulator, Muscle, Powered, Dental |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-19 |
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| D79209830 - K7 ESG-2 Electrosonograph | 2018-07-06 TMJ Vibration (Sound) Evaluation System. A lightweight headset holds highly sensitive vibration transducers over each TM joint, |
| D79240602 - Myotrode One With Gel | 2018-07-06Non-jelled TENS Electrodes for use with Myomonitor. Designed for patients with sideburns or a beard. |
| D79240602 - Myotrode One With Gel | 2018-07-06 Non-jelled TENS Electrodes for use with Myomonitor. Designed for patients with sideburns or a beard. |
| D79240702 - Myotrode One without Gel | 2018-07-06 Non-jelled TENS Electrodes for use with Myomonitor.Designed for patients with sideburns or a beard. |
| D79243003 - Myotrode SG Solid Gel TENS Electrodes | 2018-07-06 36 single-use electrodes per pouch, 2 pouches per box (72 electrodes total). A revolutionary electrode designed especially for u |
| D792N12013 - Norotrode 20 | 2018-07-06 NOROTRODES are silver-silver chloride electrodes for surface EMG applications. Contact surfaces pre-jelled with hypoallergenic |
| D792N150MES0 - MES 9000 Static Electromyography Scanner | 2018-07-06 Noromed SEMG, with broader operating ranges, greater sensitivity, and unsurpassed ability to eliminate extraneous electrical "no |