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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 a medical device manufactured by Suntech UK , Ltd.. It received FDA 510(k) clearance on 2023-02-22 under approval 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. It is manufactured by Suntech UK , Ltd.. The 510(k) number is K223492.

When was eFOLDi Scooter, Lite approved by the FDA?

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

What company makes eFOLDi Scooter, Lite?

eFOLDi Scooter, Lite is manufactured by Suntech UK , Ltd..

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

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

Other Devices by Suntech UK , Ltd.

K243110eFOLDi Navigator Powerchair (STPC-A)

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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.

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