DEN240014
- 510(k) number
- DEN240014
- Device name
- ARC-EX System
- Applicant
- Onward Medical, Inc. MA · US
- Product code
- SDO — Transcutaneous Electrical Spine Stimulator To Improv
- Decision date
- 2024-12-19
- Date received
- 2024-03-28
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Physical Medicine
Official FDA record: DEN240014
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.