FDA 510(k)

Powered Wheelchair (PL001-9001)

K-Number: K252829 · 2025-11-12

ApplicantSuzhou KD Intelligent Device Co., Ltd.

Decision Date2025-11-12

Product CodeITI

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

Powered Wheelchair (PL001-9001) is a medical device manufactured by Suzhou KD Intelligent Device Co., Ltd.. It received FDA 510(k) clearance on 2025-11-12 under approval number K252829. 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 Powered Wheelchair (PL001-9001)?

Powered Wheelchair (PL001-9001) is a medical device that received FDA 510(k) clearance on 2025-11-12. It is manufactured by Suzhou KD Intelligent Device Co., Ltd.. The 510(k) number is K252829.

When was Powered Wheelchair (PL001-9001) approved by the FDA?

Powered Wheelchair (PL001-9001) received FDA 510(k) clearance on 2025-11-12, under approval number K252829.

What company makes Powered Wheelchair (PL001-9001)?

Powered Wheelchair (PL001-9001) is manufactured by Suzhou KD Intelligent Device Co., Ltd..

What is the FDA product code for Powered Wheelchair (PL001-9001)?

The FDA product code for Powered Wheelchair (PL001-9001) is ITI.

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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.