Mobility Scooter (S3)— 510(k) K253643
Substantially EquivalentShenzhen Zhimahuaerkai Technology Co., Ltd.
FDA 510(k) clearance K253643 for Mobility Scooter (S3), Substantially Equivalent on 2026-02-18. Applicant: Shenzhen Zhimahuaerkai Technology Co., Ltd.. Device class: 2.
Summary
Shenzhen Zhimahuaerkai Technology's Mobility Scooter (S3) is filed under product code INI, motorized 3-wheeled vehicle. The record doesn't describe the scooter beyond its name and that code name.
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).
Shenzhen Zhimahuaerkai Technology filed from Shenzhen, China. FDA found it substantially equivalent 91 calendar days after receipt (November 19, 2025 to February 18, 2026).
Clearance details
- Applicant
- Shenzhen Zhimahuaerkai 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
- Shenzhen, CN
Recent devices under product code INI
view allMore clearances from Shenzhen Zhimahuaerkai Technology Co., Ltd.
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.