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FDA 510(k)

eFOLDi Scooter, Lite

K-Number: K223492 · 2023-02-22

ApplicantSuntech UK , Ltd.
Decision Date2023-02-22
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

eFOLDi Scooter, Lite is the device name listed in this FDA 510(k) record. The listed applicant is Suntech UK , Ltd.. It received FDA 510(k) clearance on 2023-02-22 under 510(k) number K223492. 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 eFOLDi Scooter, Lite?

eFOLDi Scooter, Lite is a medical device that received FDA 510(k) clearance on 2023-02-22. The listed applicant is Suntech UK , Ltd.. The 510(k) number is K223492.

When did eFOLDi Scooter, Lite receive FDA 510(k) clearance?

eFOLDi Scooter, Lite received FDA 510(k) clearance on 2023-02-22, under 510(k) number K223492.

Who is the listed applicant for eFOLDi Scooter, Lite?

The FDA 510(k) record lists Suntech UK , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for eFOLDi Scooter, Lite?

The FDA product code for eFOLDi Scooter, Lite is INI.

Other records listing Suntech UK , Ltd. as applicant

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.

K243110eFOLDi Navigator Powerchair (STPC-A)

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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