Atlas FDA

Hippocampe Marathon and Trail

FDA 510(k) clearance K251570 · decided 2025-06-23

Clearance details

K-number
K251570
Device name
Hippocampe Marathon and Trail
Applicant
Vipamat Sarl
Decision
Substantially Equivalent
Date received
2025-05-22
Decision date
2025-06-23
Days to decision
32 days
Clearance type
Traditional
Product code
IQC
Device class
2
Regulation number
890.3880
Medical specialty
Physical Medicine
Advisory committee
Physical Medicine
Location
Ploemeur, FR
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
MECHANICAL WHEELCHAIR (K120302)Novaf Andalucia 2007, SL2012-07-06
RENEGADE WHEELCHAIR (K082857)Alpha One2009-01-06
HIPPOCAMPE WHEELCHAIR (K051709)Vipamat Technologie2005-08-15
CALIFORNIA COMFORT FOUR WHEEL (K895384)Jubilee Scooters, Inc.1989-09-18
PCI CUSTOM DESIGN SERIES (K861943)Poston & Cole Intl.1986-05-30
QUALINE WHEELCHAIR PRODUCTS (K843213)Contemporary Health Sys1984-08-24
STANDARD WHEELCHAIR (K842719)Greene International Corp.1984-07-25
POIRIER VARIABLE WHEELCHAIR (K840234)Poirier S.A.1984-02-27
AMPUTEE WHEELCHAIR (K840627)Poirier S.A.1984-02-27
ARNAS WHEELCHAIR (K840631)Poirier S.A.1984-02-27
UNION WHEELCHAIR (K840625)Poirier S.A.1984-02-27
HEMIPLEGIC WHEELCHAIR (K840632)Poirier S.A.1984-02-27

Recalls involving this device

No recalls on record reference this clearance.