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FDA 510(k)

HP358EA Electrically Powered Wheelchair

K-Number: K211647 · 2022-01-04

ApplicantKunshan Hi-Fortune Health Products Co., Ltd.
Decision Date2022-01-04
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HP358EA Electrically Powered Wheelchair is a medical device manufactured by Kunshan Hi-Fortune Health Products Co., Ltd.. It received FDA 510(k) clearance on 2022-01-04 under approval number K211647. 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 HP358EA Electrically Powered Wheelchair?

HP358EA Electrically Powered Wheelchair is a medical device that received FDA 510(k) clearance on 2022-01-04. It is manufactured by Kunshan Hi-Fortune Health Products Co., Ltd.. The 510(k) number is K211647.

When was HP358EA Electrically Powered Wheelchair approved by the FDA?

HP358EA Electrically Powered Wheelchair received FDA 510(k) clearance on 2022-01-04, under approval number K211647.

What company makes HP358EA Electrically Powered Wheelchair?

HP358EA Electrically Powered Wheelchair is manufactured by Kunshan Hi-Fortune Health Products Co., Ltd..

What is the FDA product code for HP358EA Electrically Powered Wheelchair?

The FDA product code for HP358EA Electrically Powered Wheelchair 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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