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FDA 510(k)

Electric Wheelchair (HG-630)

K-Number: K251285 · 2025-07-02

ApplicantZhejiang Automwheel Tech Co., Ltd.
Decision Date2025-07-02
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Electric Wheelchair (HG-630) is a medical device manufactured by Zhejiang Automwheel Tech Co., Ltd.. It received FDA 510(k) clearance on 2025-07-02 under approval number K251285. 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 Electric Wheelchair (HG-630)?

Electric Wheelchair (HG-630) is a medical device that received FDA 510(k) clearance on 2025-07-02. It is manufactured by Zhejiang Automwheel Tech Co., Ltd.. The 510(k) number is K251285.

When was Electric Wheelchair (HG-630) approved by the FDA?

Electric Wheelchair (HG-630) received FDA 510(k) clearance on 2025-07-02, under approval number K251285.

What company makes Electric Wheelchair (HG-630)?

Electric Wheelchair (HG-630) is manufactured by Zhejiang Automwheel Tech Co., Ltd..

What is the FDA product code for Electric Wheelchair (HG-630)?

The FDA product code for Electric Wheelchair (HG-630) is ITI.

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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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