K242714

Mobility Scooter (S-01); Mobility Scooter (S-02)

510(k) number
K242714
Device name
Mobility Scooter (S-01); Mobility Scooter (S-02)
Applicant
Zhejiang Seedream Medical Equipment Co., Ltd. CN
Product code
INI — Vehicle, Motorized 3-Wheeled
Decision date
2025-01-23
Date received
2024-09-10
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Physical Medicine
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K242714
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.