| K-number | K251570 |
| Device name | Hippocampe Marathon and Trail |
| Applicant | Vipamat Sarl |
| Product code | IQC |
| Device class | Class II |
| Decision date | Jun 23, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 890.3880 |
The Hippocampe Marathon and Trail is a three-wheeled manual wheelchair designed to provide mobility to persons restricted to a seated position on various terrains, including footpaths and trails, both indoors and outdoors. It features a bent aluminum frame with adjustable seat height and headrest, disc brakes operable by a care provider, and a maximum weight capacity of 220 lbs. The device is available in three sizes and can be disassembled for storage.
Both the subject and predicate devices share a three-wheel frame design with detachable armrests, adjustable headrests, and height-adjustable backrests. The subject device has a lower weight capacity (220 lbs vs. 286 lbs) and features operational disc brakes for motion control in addition to parking brakes, whereas the predicate has only parking brakes. The subject device uses rigid-frame seating upholstery compared to the predicate's sling-style, and offers optional trail wheels similar to the predicate's standard wheels.
ISO 7176-1 (static stability), ISO 7176-3 (brake effectiveness), ISO 7176-5 (dimensions and maneuvering space), ISO 7176-7 (seating and wheel dimensions), ISO 7176-8 (static/impact/fatigue strength), ISO 7176-11 (test dummies), ISO 7176-13 (friction), ISO 7176-15 (labeling and documentation), NF ISO 7176-16 (ignition resistance), and NF ISO 7176-22 (setup procedures).
The subject device shares the same fundamental three-wheel mechanical design, materials (aluminum tubing), and intended use as the predicate device. Although the subject has a lower weight capacity (220 vs. 286 lbs) and more limited terrain scope (footpaths and trails versus sand/snow/water), these differences do not raise safety or performance concerns because the reduced capacity is properly labeled and the narrower terrain indication represents a subset of uses rather than a fundamentally different design. Both devices passed the same ISO performance standards for stability, braking, and structural strength, demonstrating substantial equivalence in safety and effectiveness.
View the full FDA submission: accessdata.fda.gov