FDA Product Code
FDA Product Code SDO — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Physical Medicine
- 21 CFR Citation
- 890.5851
510(k) Clearances — 4 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253638 | xStep (xStep) | Spinex, Inc. | 2026-04-20 | Traditional | PDF ↗ |
| K252893 | ExaStim® Stimulation System (EXA-001); ExaStim® Stimulation System (EXA-011); ReCure® Electrode Pad (PAD-003); ReCure® Electrode Pad (PAD-013) | Aneuvo | 2026-03-27 | Traditional | PDF ↗ |
| K251821 | ARC-EX System | Onward Medical, Inc. | 2025-11-14 | Traditional | PDF ↗ |
| DEN240014 | ARC-EX System | Onward Medical, Inc. | 2024-12-19 | Direct | — |
Product code SDO · Class II · Physical Medicine. Data: openFDA.