Cleared Traditional

K251570 - Hippocampe Marathon and Trail (FDA 510(k) Clearance)

Jun 2025
Decision
32d
Days
Class 2
Risk

K251570 is an FDA 510(k) clearance for the Hippocampe Marathon and Trail. This device is classified as a Wheelchair, Special Grade (Class II - Special Controls, product code IQC).

Submitted by Vipamat Sarl (Ploemeur, FR). The FDA issued a Cleared decision on June 23, 2025, 32 days after receiving the submission on May 22, 2025.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3880.

Submission Details

510(k) Number K251570 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2025
Decision Date June 23, 2025
Days to Decision 32 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code IQC - Wheelchair, Special Grade
Device Class Class II - Special Controls
CFR Regulation 21 CFR 890.3880