SDO — Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation Class II
Classification Details
- Product Code
- SDO
- Device Class
- Class II
- Regulation Number
- 890.5851
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253638 | spinex | xStep (xStep) | April 20, 2026 |
| K252893 | aneuvo | ExaStim® Stimulation System (EXA-001); ExaStim® Stimulation System (EXA-011); Re | March 27, 2026 |
| K251821 | onward medical | ARC-EX System | November 14, 2025 |
| DEN240014 | onward medical | ARC-EX System | December 19, 2024 |