Levator Elite (Model LE9011)
K-Number: K213043 · 2022-02-25
Decision Date2022-02-25
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
Levator Elite (Model LE9011) is a medical device manufactured by Shenzhen Dongdixin Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-02-25 under approval number K213043. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Levator Elite (Model LE9011)?
Levator Elite (Model LE9011) is a medical device that received FDA 510(k) clearance on 2022-02-25. It is manufactured by Shenzhen Dongdixin Technology Co., Ltd.. The 510(k) number is K213043.
When was Levator Elite (Model LE9011) approved by the FDA?
Levator Elite (Model LE9011) received FDA 510(k) clearance on 2022-02-25, under approval number K213043.
What company makes Levator Elite (Model LE9011)?
Levator Elite (Model LE9011) is manufactured by Shenzhen Dongdixin Technology Co., Ltd..
What is the FDA product code for Levator Elite (Model LE9011)?
The FDA product code for Levator Elite (Model LE9011) is IPF.
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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.