Cleared Traditional

Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes (K231166) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K231166 · Zmi Electronics , Ltd. · Gastroenterology & Urology device
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Jan 2024
Decision
268d
Days
Class 2
Risk

K231166 is an FDA 510(k) clearance for the Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Mu.... Classified as Stimulator, Electrical, Non-implantable, For Incontinence (product code KPI), Class II - Special Controls.

Submitted by Zmi Electronics , Ltd. (Kaohsiung, TW). The FDA issued a Cleared decision on January 18, 2024 after a review of 268 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5320 - the FDA gastroenterology and urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Zmi Electronics , Ltd. devices

Submission Details

510(k) Number K231166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2023
Decision Date January 18, 2024
Days to Decision 268 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
138d slower than avg
Panel avg: 130d · This submission: 268d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KPI Stimulator, Electrical, Non-implantable, For Incontinence
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5320
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KPI Stimulator, Electrical, Non-implantable, For Incontinence

All 27
Devices cleared under the same product code (KPI) and FDA review panel - the closest regulatory comparables to K231166.
Pelvic Floor Stimulator (Intrelief PFE)
K241899 · Easymed Instruments Co., Ltd. · Nov 2024
StarFormer
K234061 · Fotona D.O.O. · Jul 2024
Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013
K233576 · Shenzhen Konmed Technology Co., Ltd. · Feb 2024
Unicare (K-UNICARE-USA)
K230983 · Tenscare, Ltd. · Oct 2023
MFG-05
K230780 · Zimmer Medizinsysteme GmbH · Oct 2023
Pelvic Floor Muscle Stimulator
K230767 · Nanjing Vishee Medical Technology Co., Ltd. · Sep 2023