510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K031897Substantially Equivalent

Pf-2 Battery Operated Electric Four Wheel Power Scooter

Imc-Heart Way LLC, Fort Myers FL / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)

K031897 is the FDA 510(k) clearance record for PF-2 BATTERY OPERATED ELECTRIC FOUR WHEEL POWER SCOOTER, a class II device, cleared for Imc-Heart Way LLC on under FDA product code INI (Vehicle, Motorized 3-Wheeled). FDA records list 10 510(k) clearances for Imc-Heart Way LLC, from to . As of , FDA records show no recalls naming K031897.

Clearance record

Decision date
Received
(96 days to decision)
Product code
INI Vehicle, Motorized 3-Wheeled
Regulation
21 CFR 890.3800
Device class
Class II
Review panel
Physical Medicine
Applicant
Imc-Heart Way LLC 6140 Mid Metro Dr., Suite 6, Fort Myers FL
510(k) summary
Statement
Third party review
No

Clearances, product code INI

Trailing 12 months
22 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 20262
October 20260