HP458E Electrically Powered Wheelchair
K-Number: K212503 · 2022-01-18
Decision Date2022-01-18
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
HP458E Electrically Powered Wheelchair is a medical device manufactured by Kunshan Hi-Fortune Health Products Co., Ltd.. It received FDA 510(k) clearance on 2022-01-18 under approval number K212503. 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 HP458E Electrically Powered Wheelchair?
HP458E Electrically Powered Wheelchair is a medical device that received FDA 510(k) clearance on 2022-01-18. It is manufactured by Kunshan Hi-Fortune Health Products Co., Ltd.. The 510(k) number is K212503.
When was HP458E Electrically Powered Wheelchair approved by the FDA?
HP458E Electrically Powered Wheelchair received FDA 510(k) clearance on 2022-01-18, under approval number K212503.
What company makes HP458E Electrically Powered Wheelchair?
HP458E Electrically Powered Wheelchair is manufactured by Kunshan Hi-Fortune Health Products Co., Ltd..
What is the FDA product code for HP458E Electrically Powered Wheelchair?
The FDA product code for HP458E Electrically Powered Wheelchair is ITI.
Related Clinical Trials
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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.