Cleared Traditional

Levator Elite (Model LE9011)

K213043 · Shenzhen Dongdixin Technology Co., Ltd. · Physical Medicine

Feb 2022

Decision

156d

Days

Class 2

Risk

About This 510(k) Submission

K213043 is an FDA 510(k) clearance for the Levator Elite (Model LE9011), a Stimulator, Muscle, Powered (Class II — Special Controls, product code IPF), submitted by Shenzhen Dongdixin Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on February 25, 2022, 156 days after receiving the submission on September 22, 2021. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number	K213043 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 22, 2021
Decision Date	February 25, 2022
Days to Decision	156 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF