Incontinence Treatment Device, Model LT2061
K-Number: K171430 · 2018-03-15
Decision Date2018-03-15
Product CodeKPI
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Incontinence Treatment Device, Model LT2061 is a medical device manufactured by Shenzhen Dongdixin Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-03-15 under approval number K171430. The device is classified under product code KPI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Incontinence Treatment Device, Model LT2061?
Incontinence Treatment Device, Model LT2061 is a medical device that received FDA 510(k) clearance on 2018-03-15. It is manufactured by Shenzhen Dongdixin Technology Co., Ltd.. The 510(k) number is K171430.
When was Incontinence Treatment Device, Model LT2061 approved by the FDA?
Incontinence Treatment Device, Model LT2061 received FDA 510(k) clearance on 2018-03-15, under approval number K171430.
What company makes Incontinence Treatment Device, Model LT2061?
Incontinence Treatment Device, Model LT2061 is manufactured by Shenzhen Dongdixin Technology Co., Ltd..
What is the FDA product code for Incontinence Treatment Device, Model LT2061?
The FDA product code for Incontinence Treatment Device, Model LT2061 is KPI.
Related Clinical Trials
NCT07613931
Evaluate Advanced Pneumatic Compression Device With Revised Compression Programming for Lymphedema Treatment
NOT_YET_RECRUITING
NCT07372677
Pocket-X Gel Non-surgical Periodontal Therapy
RECRUITING
NCT05341661
Butterfly Pivotal Study
ACTIVE_NOT_RECRUITING
NCT06940752
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
ENROLLING_BY_INVITATION
NCT06868914
Phase I Trial of High-Density Theta Burst Stimulation (hdTBS)
NOT_YET_RECRUITING
NCT07548151
Guided Needle Insertion for Vascular Access
COMPLETED
Related PubMed Literature
PMID: 41915420
Analysis Model for Infant Incubator Adverse Events Using Retrieval-Augmented Generation Combined With Dual-Adapter Fine-Tuning: Development and Evaluation Study.
JMIR medical informatics (2026)
PMID: 41831468
Cardiometabolic prediction models for young people with psychosis spectrum disorders in the UK (PsyMetRiC 2.0): a retrospective, multicohort clinical prediction model study.
The lancet. Psychiatry (2026)
PMID: 41804390
Modeling In-Hospital Mortality Among Patients Undergoing Percutaneous Coronary Intervention with Acute Myocardial Infarction Complicated by Cardiogenic Shock Receiving Mechanical Circulatory Support.
Medical devices (Auckland, N.Z.) (2026)
PMID: 41533265
Modernizing Medical Software Regulation in Bangladesh: A Roadmap for Risk-Based SaMD Oversight.
Journal of medical systems (2026)
Other Devices by Shenzhen Dongdixin Technology Co., Ltd.
Related Devices (Code: KPI)
K162010HPM-6000UBTL Industries, Inc.
K161055Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15Fuji Dynamics , Ltd.
K160773Yarlap IIInternational Trade Group, Inc.
K161349Everyway Incontinence Stimulation SystemEveryway Medical Instrument Co., Ltd.
K181497HPM-6000UFBTL Industries, Inc.
K163288Pelvifine Pelvic Muscle TrainerShenzhen Konmed Technology Co., Ltd.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.