510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K242327Substantially Equivalent

Empulse M90

Concourse Assistive Technology Pty Ltd, Mount Kuring-Gai, AU / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K242327 is the FDA 510(k) clearance record for Empulse M90, a class II device, cleared for Concourse Assistive Technology Pty, Ltd. 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 one 510(k) clearance for Concourse Assistive Technology Pty, Ltd. As of , FDA records show no recalls naming K242327.

Clearance record

Decision date
Received
(126 days to decision)
Product code
ITI Wheelchair, Powered
Regulation
21 CFR 890.3860
Device class
Class II
Review panel
Physical Medicine
Applicant
Concourse Assistive Technology Pty, Ltd. 9 Hamley Rd., Mount Kuring-Gai, AU
510(k) summary
Summary PDF
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