Panels › Physical Medicine › Product code SDO · Class 2
Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation
Regulation 890.5851
3510(k)s in 12 months (4 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in SDO
| Company | 510(k)s | Recalls |
|---|---|---|
| Onward Medical, Inc. | 2 | 0 |
| Aneuvo | 1 | 0 |
| Spinex, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 20, 2026 | K253638 | xStep (xStep) Spinex, Inc. | SDO |
| Mar 27, 2026 | K252893 | ExaStim® Stimulation System (EXA-001); ExaStim® Stimulation System (EXA-011); ReCure® Electrode Pad (PAD-003); ReCure® E Aneuvo | SDO |
| Nov 14, 2025 | K251821 | ARC-EX System Onward Medical, Inc. | SDO |
| Dec 19, 2024 | DEN240014 | ARC-EX System Onward Medical, Inc. | SDO |
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