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FDA 510(k)

Wheelchair (N817)

K-Number: K251565 · 2025-10-06

ApplicantZhejiang Topwe Tools Manufacturing Co.,Ltd
Decision Date2025-10-06
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Wheelchair (N817) is a medical device manufactured by Zhejiang Topwe Tools Manufacturing Co.,Ltd. It received FDA 510(k) clearance on 2025-10-06 under approval number K251565. 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 Wheelchair (N817)?

Wheelchair (N817) is a medical device that received FDA 510(k) clearance on 2025-10-06. It is manufactured by Zhejiang Topwe Tools Manufacturing Co.,Ltd. The 510(k) number is K251565.

When was Wheelchair (N817) approved by the FDA?

Wheelchair (N817) received FDA 510(k) clearance on 2025-10-06, under approval number K251565.

What company makes Wheelchair (N817)?

Wheelchair (N817) is manufactured by Zhejiang Topwe Tools Manufacturing Co.,Ltd.

What is the FDA product code for Wheelchair (N817)?

The FDA product code for Wheelchair (N817) 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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