Electrically Powered Wheelchair -Model HP358E
K-Number: K201855 · 2021-09-28
Decision Date2021-09-28
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
Electrically Powered Wheelchair -Model HP358E is a medical device manufactured by Kunshan Hi-Fortune Health Products Co., Ltd.. It received FDA 510(k) clearance on 2021-09-28 under approval number K201855. 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 Electrically Powered Wheelchair -Model HP358E?
Electrically Powered Wheelchair -Model HP358E is a medical device that received FDA 510(k) clearance on 2021-09-28. It is manufactured by Kunshan Hi-Fortune Health Products Co., Ltd.. The 510(k) number is K201855.
When was Electrically Powered Wheelchair -Model HP358E approved by the FDA?
Electrically Powered Wheelchair -Model HP358E received FDA 510(k) clearance on 2021-09-28, under approval number K201855.
What company makes Electrically Powered Wheelchair -Model HP358E?
Electrically Powered Wheelchair -Model HP358E is manufactured by Kunshan Hi-Fortune Health Products Co., Ltd..
What is the FDA product code for Electrically Powered Wheelchair -Model HP358E?
The FDA product code for Electrically Powered Wheelchair -Model HP358E 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.