Levina Pelvic Floor Muscle Stimulator (RS-48)

Q: What is the product code of K241862?

The FDA product code is KPI – Stimulator, Electrical, Non-Implantable, For Incontinence, a Class II (moderate risk) device regulated under 21 CFR 876.5320.

FDA 510(k) K241862 · Zmi Electronics , Ltd.

Substantially Equivalent

510(k) numberK241862

Submission

Device name: Levina Pelvic Floor Muscle Stimulator (RS-48)
Applicant: Zmi Electronics , Ltd.
Kaohsiung, TW
Received: June 27, 2024
Decision date: March 27, 2025
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: KPI – Stimulator, Electrical, Non-Implantable, For Incontinence
Device class: Class II (moderate risk)
Regulation: 21 CFR 876.5320
Specialty: Gastroenterology, Urology

Other 510(k)s with product code KPI

510(k)	Device	Applicant	Decision
K260178	Pelvic Muscle Trainer (KM510, KM516B)KPI · Traditional	Shenzhen Konmed Technology Co., Ltd.	06/18/2026SE
K252601	Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer…KPI · Traditional	Hunan Accurate Bio-Medical Technology Co., Ltd.	05/14/2026SE
K252552	Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)KPI · Traditional	Shenzhen Changkun Technology Co., Ltd.	05/06/2026SE
K252831	Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924…KPI · Traditional	Dolanvy (Suzhou) Medical Technology Co., Ltd.	04/28/2026SE
K252334	PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)KPI · Traditional	Pontemedag	04/17/2026SE
K251760	Well-Life Incontinence Stimulation System (WL-2405i(P))KPI · Traditional	Well-Life Healthcare , Ltd.	02/12/2026SE
K251026	Regenesis EMS ChairKPI · Traditional	Trinity Medical Solutions	08/29/2025SE
K243079	NeuroTrac® MyoPlus Pro (MYO120U)KPI · Traditional	Verity Medical , Ltd.	06/26/2025SE
K241516	BTL-398KPI · Traditional	BTL Industries, Inc.	02/10/2025SE
K241899	Pelvic Floor Stimulator (Intrelief PFE)KPI · Traditional	Easymed Instruments Co., Ltd.	11/27/2024SE

More from Easymed Instruments Co., Ltd.

510(k)	Device	Decision
K231166	Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe…KPI · Traditional	01/18/2024SE
K180865	ZMI Self-Adhesive ElectrodesGXY · Traditional	06/28/2018SE

Questions and answers

When was Levina Pelvic Floor Muscle Stimulator (RS-48) cleared by the FDA?

Levina Pelvic Floor Muscle Stimulator (RS-48) (K241862) received a 510(k) decision of Substantially Equivalent on March 27, 2025, 273 days after the submission was received.

What is the product code of K241862?

The FDA product code is KPI – Stimulator, Electrical, Non-Implantable, For Incontinence, a Class II (moderate risk) device regulated under 21 CFR 876.5320.