Cleared Traditional

Pelvic Floor Muscle Stimulator (K230767) - FDA 510(k) Clearance

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

K230767 · Nanjing Vishee Medical Technology Co., Ltd. · Gastroenterology & Urology device
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Sep 2023
Decision
185d
Days
Class 2
Risk

K230767 is an FDA 510(k) clearance for the Pelvic Floor Muscle Stimulator. Classified as Stimulator, Electrical, Non-implantable, For Incontinence (product code KPI), Class II - Special Controls.

Submitted by Nanjing Vishee Medical Technology Co., Ltd. (Nanjing, CN). The FDA issued a Cleared decision on September 21, 2023 after a review of 185 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 Nanjing Vishee Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K230767 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2023
Decision Date September 21, 2023
Days to Decision 185 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
55d slower than avg
Panel avg: 130d · This submission: 185d
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 K230767.
Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes
K231166 · Zmi Electronics , Ltd. · Jan 2024
Unicare (K-UNICARE-USA)
K230983 · Tenscare, Ltd. · Oct 2023
MFG-05
K230780 · Zimmer Medizinsysteme GmbH · Oct 2023
Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Probe Electrode
K222528 · Well-Life Healthcare Limited · Dec 2022
Biofeedback Nerve and Muscle Stimulator
K220161 · Shenzhen Konmed Technology Co., Ltd. · Jul 2022
Keffort (MC-100, MC-100A)
K213133 · Oriental Inspiration Limited · Apr 2022