K251821
- 510(k) number
- K251821
- Device name
- ARC-EX System
- Applicant
- Onward Medical, Inc. MA · US
- Product code
- SDO — Transcutaneous Electrical Spine Stimulator To Improv
- Decision date
- 2025-11-14
- Date received
- 2025-06-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K251821.pdf
Official FDA record: K251821
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.