Incontinence Treatment Device, Model LT2061

Q: What is the product code of K171430?

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) K171430 · Shenzhen Dongdixin Technology Co., Ltd.

Substantially Equivalent

510(k) numberK171430

Submission

Device name: Incontinence Treatment Device, Model LT2061
Applicant: Shenzhen Dongdixin Technology Co., Ltd.
Shenzhen, CN
Received: May 15, 2017
Decision date: March 15, 2018
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement 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

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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
K241862	Levina Pelvic Floor Muscle Stimulator (RS-48)KPI · Traditional	Zmi Electronics , Ltd.	03/27/2025SE
K241516	BTL-398KPI · Traditional	BTL Industries, Inc.	02/10/2025SE

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Questions and answers

When was Incontinence Treatment Device, Model LT2061 cleared by the FDA?

Incontinence Treatment Device, Model LT2061 (K171430) received a 510(k) decision of Substantially Equivalent on March 15, 2018, 304 days after the submission was received.

What is the product code of K171430?

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