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510(k) K251570

Hippocampe Marathon and Trail by Vipamat Sarl — Product Code IQC

K251570 is an FDA 510(k) premarket notification submitted by Vipamat Sarl for the device "Hippocampe Marathon and Trail". The FDA issued a decision of Substantially Equivalent on June 23, 2025. The device falls under product code IQC (Wheelchair, Special Grade), a Class II device regulated under 21 CFR 890.3880.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2025
Date Received
May 22, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wheelchair, Special Grade
Device Class
Class II
Regulation Number
890.3880
Review Panel
PM
Submission Type

Other clearances for product code IQC

  • K120302 — MECHANICAL WHEELCHAIR (July 6, 2012)
  • K082857 — RENEGADE WHEELCHAIR (January 6, 2009)
  • K051709 — HIPPOCAMPE WHEELCHAIR (August 15, 2005)
  • K895384 — CALIFORNIA COMFORT FOUR WHEEL (September 18, 1989)
  • K861943 — PCI CUSTOM DESIGN SERIES (May 30, 1986)
  • K843213 — QUALINE WHEELCHAIR PRODUCTS (August 24, 1984)
  • K842719 — STANDARD WHEELCHAIR (July 25, 1984)
  • K840634 — OLYMPIC & BASKET WHEELCHAIRS (February 27, 1984)
  • K840632 — HEMIPLEGIC WHEELCHAIR (February 27, 1984)
  • K840630 — POIRIER REGLADE WHEELCHAIR (February 27, 1984)

FDA data resources