510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K052673Substantially Equivalent

King I Powered Scooter, Model Ctl-11

King I Tech Corporation, Hsin-Chu City, TW / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K052673 is the FDA 510(k) clearance record for KING I POWERED SCOOTER, MODEL CTL-11, a class II device, cleared for King I Tech Corporation on under FDA product code INI (Vehicle, Motorized 3-Wheeled). FDA records list one 510(k) clearance for King I Tech Corporation. As of , FDA records show no recalls naming K052673.

Clearance record

Decision date
Received
(20 days to decision)
Product code
INI Vehicle, Motorized 3-Wheeled
Regulation
21 CFR 890.3800
Device class
Class II
Review panel
Physical Medicine
Applicant
King I Tech Corporation # 58, Fu-Chiun St., Hsin-Chu City, TW
510(k) summary
Summary PDF
Third party review
No

Clearances, product code INI

Trailing 12 months
24 clearances under product code INI in the twelve months to October 2026, January 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code INI, trailing twelve months
MonthClearances
November 20251
December 20252
January 20265
February 20262
March 20262
April 20261
May 20261
June 20262
July 20262
August 20262
September 20264
October 20260