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FDA 510(k)

Electrically powered wheelchair (KZ301B)

K-Number: K252494 · 2025-12-05

Decision Date2025-12-05
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Electrically powered wheelchair (KZ301B) is a medical device manufactured by Nanjing Kangni Smart Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-12-05 under approval number K252494. 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 Electrically powered wheelchair (KZ301B)?

Electrically powered wheelchair (KZ301B) is a medical device that received FDA 510(k) clearance on 2025-12-05. It is manufactured by Nanjing Kangni Smart Technology Co., Ltd.. The 510(k) number is K252494.

When was Electrically powered wheelchair (KZ301B) approved by the FDA?

Electrically powered wheelchair (KZ301B) received FDA 510(k) clearance on 2025-12-05, under approval number K252494.

What company makes Electrically powered wheelchair (KZ301B)?

Electrically powered wheelchair (KZ301B) is manufactured by Nanjing Kangni Smart Technology Co., Ltd..

What is the FDA product code for Electrically powered wheelchair (KZ301B)?

The FDA product code for Electrically powered wheelchair (KZ301B) is ITI.

Related Clinical Trials

Other Devices by Nanjing Kangni Smart Technology Co., Ltd.

Related Devices (Code: ITI)

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.