Mobility Scooter (CL-Q3, CL-Q4)— 510(k) K253631
Substantially EquivalentZhejiang Wei Ling New Energy Technology Co., Ltd.
FDA 510(k) clearance K253631 for Mobility Scooter (CL-Q3, CL-Q4), Substantially Equivalent on 2026-02-23. Applicant: Zhejiang Wei Ling New Energy Technology Co., Ltd.. Device class: 2.
Summary
Zhejiang Wei Ling New Energy Technology's Mobility Scooter comes in two models, CL-Q3 and CL-Q4, filed under product code INI, motorized 3-wheeled vehicle. The record doesn't say how they differ.
Class II, 21 CFR 890.3800. Physical Medicine is both the classification panel and the review panel. It came in as a Traditional 510(k).
Zhejiang Wei Ling New Energy Technology filed from Taizhou, China. Review took 96 calendar days (November 19, 2025 to February 23, 2026), ending in a substantially equivalent decision.
Clearance details
- Applicant
- Zhejiang Wei Ling New Energy 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
- Taizhou, CN
Recent devices under product code INI
view allAdverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.