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FDA 510(k)

Electric Wheelchair (Model P2)

K-Number: K252428 · 2025-09-18

Decision Date2025-09-18
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Electric Wheelchair (Model P2) is a medical device manufactured by Superpi Robot Co., Ltd.. It received FDA 510(k) clearance on 2025-09-18 under approval number K252428. 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 (Model P2)?

Electric Wheelchair (Model P2) is a medical device that received FDA 510(k) clearance on 2025-09-18. It is manufactured by Superpi Robot Co., Ltd.. The 510(k) number is K252428.

When was Electric Wheelchair (Model P2) approved by the FDA?

Electric Wheelchair (Model P2) received FDA 510(k) clearance on 2025-09-18, under approval number K252428.

What company makes Electric Wheelchair (Model P2)?

Electric Wheelchair (Model P2) is manufactured by Superpi Robot Co., Ltd..

What is the FDA product code for Electric Wheelchair (Model P2)?

The FDA product code for Electric Wheelchair (Model P2) is ITI.

Related Clinical Trials

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.