Clearance Summary
ARC-EX System received FDA 510(k) clearance under submission number DEN240014, sponsored by Onward Medical, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2024-12-19.
- Submission: DEN240014
- Applicant / Sponsor: Onward Medical, Inc.
- Clearance pathway: Direct
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5851
- Decision date: 2024-12-19
Classification & Regulation
This clearance is catalogued under FDA product code SDO and 21 CFR 890.5851, within the Physical Medicine review panel as a Class II device.