Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K120526Substantially Equivalent

Yuyue K2 Wheelchair, Yuyue K4 Wheelchair

Jiangsu Yuyue Medical Equipment & Supply Co., Ltd., Northbrook IL / Traditional, Substantially Equivalent

K120526 is the FDA 510(k) clearance record for YUYUE K2 WHEELCHAIR, YUYUE K4 WHEELCHAIR, a class I device, cleared for Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. on under FDA product code IOR (Wheelchair, Mechanical). FDA's definition for product code IOR reads: "A mechanical wheelchair is a manually 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”...". FDA records list 15 510(k) clearances for Jiangsu Yuyue Medical Equipment & Supply Co., Ltd., from to . As of , FDA records show no recalls naming K120526.

Clearance record

Decision date
Received
(15 days to decision)
Product code
IOR Wheelchair, Mechanical
Regulation
21 CFR 890.3850
Device class
Class I
Review panel
Physical Medicine
Applicant
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. 333 Pfingsten Rd., Northbrook IL
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code IOR

Trailing 12 months
21 clearances under product code IOR in the twelve months to October 2026, September 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code IOR, trailing twelve months
MonthClearances
November 20252
December 20252
January 20262
February 20260
March 20261
April 20261
May 20262
June 20264
July 20261
August 20261
September 20265
October 20260