FDA 510(k)

eFOLDi Navigator Powerchair (STPC-A)

K-Number: K243110 · 2025-05-08

Decision Date2025-05-08

Product CodeITI

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

eFOLDi Navigator Powerchair (STPC-A) is a medical device manufactured by Suntech UK , Ltd.. It received FDA 510(k) clearance on 2025-05-08 under approval number K243110. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the eFOLDi Navigator Powerchair (STPC-A)?

eFOLDi Navigator Powerchair (STPC-A) is a medical device that received FDA 510(k) clearance on 2025-05-08. It is manufactured by Suntech UK , Ltd.. The 510(k) number is K243110.

When was eFOLDi Navigator Powerchair (STPC-A) approved by the FDA?

eFOLDi Navigator Powerchair (STPC-A) received FDA 510(k) clearance on 2025-05-08, under approval number K243110.

What company makes eFOLDi Navigator Powerchair (STPC-A)?

eFOLDi Navigator Powerchair (STPC-A) is manufactured by Suntech UK , Ltd..

What is the FDA product code for eFOLDi Navigator Powerchair (STPC-A)?

The FDA product code for eFOLDi Navigator Powerchair (STPC-A) is ITI.

Other Devices by Suntech UK , Ltd.

K223492eFOLDi Scooter, Lite

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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.