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FDA 510(k)

eFOLDi Navigator Powerchair (STPC-A)

K-Number: K243110 · 2025-05-08

ApplicantSuntech UK , Ltd.
Decision Date2025-05-08
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

eFOLDi Navigator Powerchair (STPC-A) 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 2025-05-08 under 510(k) 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. The listed applicant is Suntech UK , Ltd.. The 510(k) number is K243110.

When did eFOLDi Navigator Powerchair (STPC-A) receive FDA 510(k) clearance?

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

Who is the listed applicant for eFOLDi Navigator Powerchair (STPC-A)?

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 Navigator Powerchair (STPC-A)?

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

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.

K223492eFOLDi Scooter, Lite

Related Devices (Code: ITI)

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.

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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.

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