Cleared Traditional

K213043 - Levator Elite (Model LE9011)

K213043 is the FDA 510(k) clearance for Levator Elite (Model LE9011) by Shenzhen Dongdixin Technology Co., Ltd.. It is a Class 2 Physical Medicine device (product code IPF) cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K213043 · Shenzhen Dongdixin Technology Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2022
Decision
156d
Days
Class 2
Risk

K213043 is an FDA 510(k) clearance for the Levator Elite (Model LE9011). Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Shenzhen Dongdixin Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on February 25, 2022 after a review of 156 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5850 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Shenzhen Dongdixin Technology Co., Ltd. devices

Submission Details

510(k) Number K213043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 115d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IPF Stimulator, Muscle, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5850
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - IPF Stimulator, Muscle, Powered

All 134
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K213043.
MyOnyx System
K213197 · Thought Technology , Ltd. · Jun 2022
Motive Knee Wrap
K220738 · Cymedica Orthopedics, Inc. · May 2022
geko W-3
K220327 · Firstkind Limited · Mar 2022
TimeWaver Frequency
K212832 · Timewaver Production GmbH · Dec 2021
geko W-2
K212762 · Firstkind Limited · Nov 2021
MyoWorx TM20
K192746 · Myoworx, Inc. · Oct 2021