510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K003449Substantially Equivalent

E Motion Wheelchair Drive System (Power-Assist for Manual Wheelchairs)

Ulrich Alber GmbH, Great Neck NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K003449 is the FDA 510(k) clearance record for E MOTION WHEELCHAIR DRIVE SYSTEM (POWER-ASSIST FOR MANUAL WHEELCHAIRS), a class II device, cleared for Ulrich Alber GmbH & Co. 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 2 510(k) clearances for Ulrich Alber GmbH & Co., from to . As of , FDA records show no recalls naming K003449.

Clearance record

Decision date
Received
(129 days to decision)
Product code
ITI Wheelchair, Powered
Regulation
21 CFR 890.3860
Device class
Class II
Review panel
Physical Medicine
Applicant
Ulrich Alber GmbH & Co. 55 Northern Blvd., Great Neck NY
510(k) summary
Summary
Third party review
No

Clearances, product code ITI

Trailing 12 months
37 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 20265
October 20260