510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K063475Substantially Equivalent

Imc-Heartway, Llc Electric Wheelchair, Model Tiara (P4as)

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

K063475 is the FDA 510(k) clearance record for IMC-HEARTWAY, LLC ELECTRIC WHEELCHAIR, MODEL TIARA (P4AS), a class II device, cleared for Imc-Heart Way LLC on under FDA product code ITI (Wheelchair, Powered). FDA's definition for product code ITI reads: "A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. FDA interprets “mobility to persons restricted to a sitting position” to...". FDA records list 10 510(k) clearances for Imc-Heart Way LLC, from to . As of , FDA records show no recalls naming K063475.

Clearance record

Decision date
Received
(68 days to decision)
Product code
ITI Wheelchair, Powered
Regulation
21 CFR 890.3860
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 ITI

Trailing 12 months
36 clearances under product code ITI in the twelve months to October 2026, March 2026 the highest month at 7.
Show the numbers
Monthly 510(k) clearances under FDA product code ITI, trailing twelve months
MonthClearances
November 20253
December 20253
January 20262
February 20263
March 20267
April 20263
May 20261
June 20266
July 20263
August 20261
September 20264
October 20260