Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K022700Substantially Equivalent

Deluxe Manual Wheelchair Hw 4000

Forever Young Ent. Co., Ltd., Hsin-Chu City,, CN / Traditional, Substantially Equivalent

K022700 is the FDA 510(k) clearance record for DELUXE MANUAL WHEELCHAIR HW 4000, a class I device, cleared for Forever Young Ent. 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 2 510(k) clearances for Forever Young Ent. Co., Ltd. As of , FDA records show no recalls naming K022700.

Clearance record

Decision date
Received
(31 days to decision)
Product code
IOR Wheelchair, Mechanical
Regulation
21 CFR 890.3850
Device class
Class I
Review panel
Physical Medicine
Applicant
Forever Young Ent. Co., Ltd. # 58 Fu-Chiun St., Hsin-Chu City,, CN
510(k) summary
Statement
Third party review
No

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