Cleared Traditional

Incontinence Treatment Device, Model LT2061

K171430 · Shenzhen Dongdixin Technology Co., Ltd. · Gastroenterology & Urology
Mar 2018
Decision
304d
Days
Class 2
Risk

About This 510(k) Submission

K171430 is an FDA 510(k) clearance for the Incontinence Treatment Device, Model LT2061, a Stimulator, Electrical, Non-implantable, For Incontinence (Class II — Special Controls, product code KPI), submitted by Shenzhen Dongdixin Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on March 15, 2018, 304 days after receiving the submission on May 15, 2017. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5320.

Submission Details

510(k) Number K171430 FDA.gov
FDA Decision Cleared SESE
Date Received May 15, 2017
Decision Date March 15, 2018
Days to Decision 304 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement

Device Classification

Product Code KPI — Stimulator, Electrical, Non-implantable, For Incontinence
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5320

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