| Primary Device ID | 04650075330036 |
| NIH Device Record Key | e2a1042d-1fc6-4e93-bc47-6f029fcffdb7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Neuro-Audio |
| Version Model Number | Neuro-Audio |
| Company DUNS | 643212926 |
| Company Name | NEUROSOFT, OOO |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 617 8403253 |
| Jjabre@teleemg.com | |
| Phone | 617 8403253 |
| Jjabre@teleemg.com | |
| Phone | 617 8403253 |
| Jjabre@teleemg.com | |
| Phone | 617 8403253 |
| Jjabre@teleemg.com | |
| Phone | 617 8403253 |
| Jjabre@teleemg.com | |
| Phone | 617 8403253 |
| Jjabre@teleemg.com | |
| Phone | 617 8403253 |
| Jjabre@teleemg.com | |
| Phone | 617 8403253 |
| Jjabre@teleemg.com | |
| Phone | 617 8403253 |
| Jjabre@teleemg.com | |
| Phone | 617 8403253 |
| Jjabre@teleemg.com | |
| Phone | 617 8403253 |
| Jjabre@teleemg.com | |
| Phone | 617 8403253 |
| Jjabre@teleemg.com | |
| Phone | 617 8403253 |
| Jjabre@teleemg.com | |
| Phone | 617 8403253 |
| Jjabre@teleemg.com | |
| Phone | 617 8403253 |
| Jjabre@teleemg.com | |
| Phone | 617 8403253 |
| Jjabre@teleemg.com | |
| Phone | 617 8403253 |
| Jjabre@teleemg.com | |
| Phone | 617 8403253 |
| Jjabre@teleemg.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04650075330036 [Primary] |
| GWJ | Stimulator, Auditory, Evoked Response |
| 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 | 2016-09-22 |
| 04650075335895 - CloudTMS Edge for OCD | 2024-01-22 The CloudTMS Edge stimulator is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-C |
| 04650075335932 - CoudTMS Edge for OCD | 2024-01-22 No description |
| 04650075335949 - CloudTMS Edge for OCD | 2024-01-22 No description |
| 04650075333792 - CloudTMS for OCD | 2023-12-22 The Cloud TMS stimulator is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compu |
| 04650075333952 - CloudTMS for OCD | 2023-12-22 No description. |
| 04650075333969 - CloudTMS for OCD | 2023-12-22 No description. |
| 04650075332078 - Steadys-Step | 2023-08-22 System is intended for objective gait analysis and biofeedback gait training based on EMG and IMU (Inertial Measurement Unit) da |
| 04650075334003 - aTymp | 2023-02-10 The aTymp system is a portable audiometric device intended for use in conduction of diagnostic hearing evaluations and assisting |