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FDA 510(k)

Mobility Scooter (Model X-01, X-02)

K-Number: K242975 · 2025-05-07

ApplicantWuyi Aichi Industry & Trade Co., Ltd.
Decision Date2025-05-07
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Mobility Scooter (Model X-01, X-02) is the device name listed in this FDA 510(k) record. The listed applicant is Wuyi Aichi Industry & Trade Co., Ltd.. It received FDA 510(k) clearance on 2025-05-07 under 510(k) 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. The listed applicant is Wuyi Aichi Industry & Trade Co., Ltd.. The 510(k) number is K242975.

When did Mobility Scooter (Model X-01, X-02) receive FDA 510(k) clearance?

Mobility Scooter (Model X-01, X-02) received FDA 510(k) clearance on 2025-05-07, under 510(k) number K242975.

Who is the listed applicant for Mobility Scooter (Model X-01, X-02)?

The FDA 510(k) record lists Wuyi Aichi Industry & Trade Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Devices (Code: INI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260176Mobility Scooter (W3483, W3483A)Zhejiang Innuovo Rehabilitation Devices Co.,LtdK260094Mobility Scooter (W3465, W3902 (S50 Carbon))Zhejiang Innuovo Rehabilitation Devices Co.,LtdK261232IERO Mobility Scooter (IERO-01)Jochu Technology Co., Ltd.K261163Mobility Scooter (R200)Yongkang Ruihe Metal Product Co., Ltd.K253257Virgo Mobility Scooter (Virgo-D,Virgo-F)Jiangsu Intco Medical Products Co., Ltd.K253600Scooter (YD-03)Yurob Rehabilitation Medical Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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