MOBILITY SCOOTER (YQ-401,YQ- 401A,YQ-403,YQ-403A)— 510(k) K262553

Substantially Equivalent

Zhejiang Kailang Technology Co., Ltd.

FDA 510(k) clearance K262553 for MOBILITY SCOOTER (YQ-401,YQ- 401A,YQ-403,YQ-403A), Substantially Equivalent on 2026-09-29. Applicant: Zhejiang Kailang Technology Co., Ltd.. Device class: 2.

Summary

Zhejiang Kailang Technology Co., Ltd. cleared four mobility scooter models in one submission: YQ-401, YQ-401A, YQ-403, and YQ-403A. They're filed under INI, motorized three-wheeled vehicles. The record doesn't say how the "A" variants differ.

Class II, 21 CFR 890.3800. The Physical Medicine panel reviewed it as a Traditional 510(k).

Kailang filed from Yongkang, China. Review took 67 days (July 24 to September 29, 2026).

Clearance details

Applicant
Zhejiang Kailang Technology Co., Ltd.
Product code
Product code INI
Device class
Class 2
Regulation
21 CFR 890.3800
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Yongkang, CN
Download summary PDFView on FDA.gov ↗

Recent devices under product code INI

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Adverse events under product code INI

product code INI
Injury
171
Other
1
Total
172

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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