K252893 is an FDA 510(k) clearance for the ExaStim® Stimulation System (EXA-001). 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 Aneuvo (Los Angeles, US). The FDA issued a Cleared decision on March 27, 2026, 197 days after receiving the submission on September 11, 2025.
This device falls under the Physical Medicine 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 | K252893 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 11, 2025 |
| Decision Date | March 27, 2026 |
| Days to Decision | 197 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| 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. |