i3 Foldable Mobility Scooter
K-Number: K191356 · 2022-01-11
ApplicantPuc Perfect Union Co., Ltd.
Decision Date2022-01-11
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
i3 Foldable Mobility Scooter is a medical device manufactured by Puc Perfect Union Co., Ltd.. It received FDA 510(k) clearance on 2022-01-11 under approval number K191356. The device is classified under product code INI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the i3 Foldable Mobility Scooter?
i3 Foldable Mobility Scooter is a medical device that received FDA 510(k) clearance on 2022-01-11. It is manufactured by Puc Perfect Union Co., Ltd.. The 510(k) number is K191356.
When was i3 Foldable Mobility Scooter approved by the FDA?
i3 Foldable Mobility Scooter received FDA 510(k) clearance on 2022-01-11, under approval number K191356.
What company makes i3 Foldable Mobility Scooter?
i3 Foldable Mobility Scooter is manufactured by Puc Perfect Union Co., Ltd..
What is the FDA product code for i3 Foldable Mobility Scooter?
The FDA product code for i3 Foldable Mobility Scooter is INI.
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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.