Electrical Scooter (SM4226)— 510(k) K252813

Name: FDA 510(k) clearance K252813
Creator: U.S. Food and Drug Administration
Published: 2026-03-17

Substantially Equivalent

Lerado Zhongshan Peaceful Cove Business Trading Co., Ltd.

FDA 510(k) clearance K252813 for Electrical Scooter (SM4226), Substantially Equivalent on 2026-03-17. Applicant: Lerado Zhongshan Peaceful Cove Business Trading Co., Ltd.. Device class: 2.

Summary

Lerado Zhongshan Peaceful Cove Business Trading's Electrical Scooter (SM4226) is filed under INI, motorized 3-wheeled vehicles. The name is generic apart from the SM4226 designation.

Class II, 21 CFR 890.3800. Physical Medicine is both the classification panel and the review panel, and it came in as a Traditional 510(k).

Lerado Zhongshan Peaceful Cove Business Trading filed from Zhongshan, China. Review took 194 calendar days (September 4, 2025 to March 17, 2026).

Clearance details

Applicant: Lerado Zhongshan Peaceful Cove Business Trading Co., Ltd.
Product code: Product code INI
Device class: Class 2
Regulation: 21 CFR 890.3800
Advisory panel: Physical Medicine
Date received: 2025-09-04
Decision date: 2026-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zhongshan, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code INI

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K262213 — Power Mobility Scooter (MA03)2026-09-29
K262553 — MOBILITY SCOOTER (YQ-401,YQ- 401A,YQ-403,YQ-403A)2026-09-29
K261078 — Electric Scooter (FNS01,FNS03)2026-09-24
K261859 — Electric Scooter (FDB08, FDB08A, FDB12)2026-09-19
K260094 — Mobility Scooter (W3465, W3902 (S50 Carbon))2026-08-10

Adverse events under product code INI

product code INI

Injury: 171
Other: 1
Total: 172

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.