510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K915416Substantially Equivalent

Fymco Flyer

Motion Dynamics, Concord, Ontario Canada, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K915416 is the FDA 510(k) clearance record for FYMCO FLYER, a class II device, cleared for Motion Dynamics on under FDA product code INI (Vehicle, Motorized 3-Wheeled). FDA records list one 510(k) clearance for Motion Dynamics. As of , FDA records show no recalls naming K915416.

Clearance record

Decision date
Received
(245 days to decision)
Product code
INI Vehicle, Motorized 3-Wheeled
Regulation
21 CFR 890.3800
Device class
Class II
Review panel
Physical Medicine
Applicant
Motion Dynamics 110 Cidermill Ave., Concord, Ontario Canada, CA
510(k) summary
Summary
Third party review
No

Clearances, product code INI

Trailing 12 months
24 clearances under product code INI in the twelve months to October 2026, January 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code INI, trailing twelve months
MonthClearances
November 20251
December 20252
January 20265
February 20262
March 20262
April 20261
May 20261
June 20262
July 20262
August 20262
September 20264
October 20260