Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K033031Substantially Equivalent

Taiwan King Strong Tc 03 Mechanical Wheelchair

Taiwan King Strong Co., Ltd., Hsin Chu City, TW / Traditional, Substantially Equivalent

K033031 is the FDA 510(k) clearance record for TAIWAN KING STRONG TC 03 MECHANICAL WHEELCHAIR, a class I device, cleared for Taiwan King Strong 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 4 510(k) clearances for Taiwan King Strong Co., Ltd., from to . As of , FDA records show no recalls naming K033031.

Clearance record

Decision date
Received
(67 days to decision)
Product code
IOR Wheelchair, Mechanical
Regulation
21 CFR 890.3850
Device class
Class I
Review panel
Physical Medicine
Applicant
Taiwan King Strong Co., Ltd. 58 Fu-Chiun St., Hsin Chu City, TW
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