Mobility Scooter (S-01); Mobility Scooter (S-02)— 510(k) K242714

Substantially Equivalent

Zhejiang Seedream Medical Equipment Co., Ltd.

FDA 510(k) clearance K242714 for Mobility Scooter (S-01); Mobility Scooter (S-02), Substantially Equivalent on 2025-01-23. Applicant: Zhejiang Seedream Medical Equipment Co., Ltd..

Clearance details

Applicant: Zhejiang Seedream Medical Equipment Co., Ltd.
Product code: Code INI
Advisory panel: Physical Medicine
Date received: 2024-09-10
Decision date: 2025-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jinhua, CN

Download summary PDF View on FDA.gov ↗

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.