DEN240014 is an FDA 510(k) submission for the ARC-EX System. This device is classified as a Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation (Class II - Special Controls, product code SDO).
Submitted by Onward Medical, Inc. (Boston, US). The FDA issued a Not Cleared (DENG) decision on December 19, 2024.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 890.5851. A Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation Is A Device That Can Be Programmed To Apply An Electrical Current Via Electrodes On A Patient's Skin Over The Spine To Improve Muscle Strength And Sensation After Neurological Deficit..
| 510(k) Number | DEN240014 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | March 28, 2024 |
| Decision Date | December 19, 2024 |
| Days to Decision | 266 days |
| Submission Type | Direct |
| Review Panel | Neurology (NE) |
| Summary | - |
| Product Code | SDO - Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5851 |
| Definition | A Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation Is A Device That Can Be Programmed To Apply An Electrical Current Via Electrodes On A Patient's Skin Over The Spine To Improve Muscle Strength And Sensation After Neurological Deficit. |