K251821 is an FDA 510(k) clearance 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 Cleared decision on November 14, 2025, 154 days after receiving the submission on June 13, 2025.
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 | K251821 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 13, 2025 |
| Decision Date | November 14, 2025 |
| Days to Decision | 154 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| 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. |