Clearance Summary
Hippocampe Marathon and Trail received FDA 510(k) clearance under submission number K251570, sponsored by Vipamat Sarl. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2025-06-23.
- Submission: K251570
- Applicant / Sponsor: Vipamat Sarl
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3880
- Decision date: 2025-06-23
Classification & Regulation
This clearance is catalogued under FDA product code IQC and 21 CFR 890.3880, within the Physical Medicine review panel as a Class II device.