Cleared Traditional

K241862 - Levina Pelvic Floor Muscle Stimulator (RS-48) (FDA 510(k) Clearance)

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

K241862 · Zmi Electronics , Ltd. · Gastroenterology & Urology device
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Mar 2025
Decision
273d
Days
Class 2
Risk

K241862 is an FDA 510(k) clearance for the Levina Pelvic Floor Muscle Stimulator (RS-48). 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 March 27, 2025 after a review of 273 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 K241862 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2024
Decision Date March 27, 2025
Days to Decision 273 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
143d slower than avg
Panel avg: 130d · This submission: 273d
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 92
Devices cleared under the same product code (KPI) and FDA review panel - the closest regulatory comparables to K241862.
Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927)
K252831 · Dolanvy (Suzhou) Medical Technology Co., Ltd. · Apr 2026
PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)
K252334 · Pontemedag · Apr 2026
Well-Life Incontinence Stimulation System (WL-2405i(P))
K251760 · Well-Life Healthcare , Ltd. · Feb 2026
Regenesis EMS Chair
K251026 · Trinity Medical Solutions · Aug 2025
NeuroTrac® MyoPlus Pro (MYO120U)
K243079 · Verity Medical , Ltd. · Jun 2025
BTL-398
K241516 · BTL Industries, Inc. · Feb 2025