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510(k) Data Aggregation
K Number
K251570Device Name
Hippocampe Marathon and Trail
Manufacturer
Date Cleared
2025-06-23
(32 days)
Product Code
Regulation Number
890.3880Why did this record match?
Applicant Name (Manufacturer) :
Vipamat Sarl
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Hippocampe Marathon and Trail is indicated to provide mobility to persons restricted to a seated position on various terrains, including footpaths and trails.
Device Description
The Hippocampe Marathon and Trail is an occupant or care provider propelled manual operated wheelchair. The Hippocampe Marathon and Trail is designed for everyday use as well as recreational activity such as running and trail running, in the following environments:
- Indoors and outdoors;
- Over smooth, rough, and uneven ground;
- Over soft and hard surfaces;
- Over small obstacles, like door jams; and
- Up, down and across slopes.
The Hippocampe Marathon and Trail is a three-wheel triangular wheelchair comprised of bent aluminum tubing frame that are bent, joined, fastened, and/or coupled with connectors to form a frame. The frame consists primarily of a lower frame, adjustable height seat back frame, adjustable headrest, push bar and push bar frame, tubing clamp connectors, footrest, arm rests, rear axle assembly, and front fork and axle assembly. Once assembled, the wheelchair frame is fixed. The recline of the seat back frame can be adjusted with depth adjustment screws at the base of the seat back frame. The upholstery is attached to the frame using nylon straps and buckles and is fire resistant. A rigid plastic open basket-like structure located in the middle of the lower frame and behind the front fork assembled provides the occupant a footrest and has a removable layer of foam. On the push bar are control levers for disc brakes of the rear wheels which are operated by the occupant's care provider. The disc brakes also act as parking brakes and are activated by the care provider. The Hippocampe Marathon and Trail can be easily assembled and disassembled for stowage or storage by detaching the lower frame of the armrest and folding the seat back frame forwards. The wheelchair is available in three sizes: medium, large and extra-large. The maximum weight capacity of Hippocampe Marathon and Trail is 220 lbs.
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