SDO
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5851
- Medical specialty
- Physical Medicine
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| xStep (xStep) (K253638) | Spinex, Inc. | 2026-04-20 |
| ExaStim® Stimulation System (EXA-001); ExaStim® Stimulation System (EXA-011); ReCure® Electrode Pad (PAD-003); ReCure® Electrode Pad (PAD-013) (K252893) | Aneuvo | 2026-03-27 |
| ARC-EX System (K251821) | Onward Medical, Inc. | 2025-11-14 |
| ARC-EX System (DEN240014) | Onward Medical, Inc. | 2024-12-19 |
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Every clearance here is in the API, with alerts when new ones post.