Mobility Scooter (Model X-01, X-02)
K-Number: K242975 · 2025-05-07
Decision Date2025-05-07
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
Mobility Scooter (Model X-01, X-02) is a medical device manufactured by Wuyi Aichi Industry & Trade Co., Ltd.. It received FDA 510(k) clearance on 2025-05-07 under approval number K242975. The device is classified under product code INI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Mobility Scooter (Model X-01, X-02)?
Mobility Scooter (Model X-01, X-02) is a medical device that received FDA 510(k) clearance on 2025-05-07. It is manufactured by Wuyi Aichi Industry & Trade Co., Ltd.. The 510(k) number is K242975.
When was Mobility Scooter (Model X-01, X-02) approved by the FDA?
Mobility Scooter (Model X-01, X-02) received FDA 510(k) clearance on 2025-05-07, under approval number K242975.
What company makes Mobility Scooter (Model X-01, X-02)?
Mobility Scooter (Model X-01, X-02) is manufactured by Wuyi Aichi Industry & Trade Co., Ltd..
What is the FDA product code for Mobility Scooter (Model X-01, X-02)?
The FDA product code for Mobility Scooter (Model X-01, X-02) is INI.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.