Levator Elite (Model LE9011)— 510(k) K213043

Name: FDA 510(k) clearance K213043
Creator: U.S. Food and Drug Administration
Published: 2022-02-25

Substantially Equivalent

Shenzhen Dongdixin Technology Co., Ltd.

FDA 510(k) clearance K213043 for Levator Elite (Model LE9011), Substantially Equivalent on 2022-02-25. Applicant: Shenzhen Dongdixin Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shenzhen Dongdixin Technology Co., Ltd.
Product code: Code IPF
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 2021-09-22
Decision date: 2022-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.