510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K954378Substantially Equivalent

Formula IV Electric Mobility Vehicle

Aerotek, Renfrew, Ontario, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K954378 is the FDA 510(k) clearance record for FORMULA IV ELECTRIC MOBILITY VEHICLE, a class II device, cleared for Aerotek on under FDA product code INI (Vehicle, Motorized 3-Wheeled). FDA records list one 510(k) clearance for Aerotek. As of , FDA records show no recalls naming K954378.

Clearance record

Decision date
Received
(310 days to decision)
Product code
INI Vehicle, Motorized 3-Wheeled
Regulation
21 CFR 890.3800
Device class
Class II
Review panel
Physical Medicine
Applicant
Aerotek P.O. Box 394, Renfrew, Ontario, 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