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FDA 510(k)

Powered wheelchair (mobility robot) (M4, M4U)

K-Number: K242358 · 2025-04-03

ApplicantXsto Co., Ltd.
Decision Date2025-04-03
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Powered wheelchair (mobility robot) (M4, M4U) is a medical device manufactured by Xsto Co., Ltd.. It received FDA 510(k) clearance on 2025-04-03 under approval number K242358. 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 (mobility robot) (M4, M4U)?

Powered wheelchair (mobility robot) (M4, M4U) is a medical device that received FDA 510(k) clearance on 2025-04-03. It is manufactured by Xsto Co., Ltd.. The 510(k) number is K242358.

When was Powered wheelchair (mobility robot) (M4, M4U) approved by the FDA?

Powered wheelchair (mobility robot) (M4, M4U) received FDA 510(k) clearance on 2025-04-03, under approval number K242358.

What company makes Powered wheelchair (mobility robot) (M4, M4U)?

Powered wheelchair (mobility robot) (M4, M4U) is manufactured by Xsto Co., Ltd..

What is the FDA product code for Powered wheelchair (mobility robot) (M4, M4U)?

The FDA product code for Powered wheelchair (mobility robot) (M4, M4U) 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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