Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Dongdixin Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-03-15 under 510(k) 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. The listed applicant is Shenzhen Dongdixin Technology Co., Ltd.. The 510(k) number is K171430.

When did Incontinence Treatment Device, Model LT2061 receive FDA 510(k) clearance?

Incontinence Treatment Device, Model LT2061 received FDA 510(k) clearance on 2018-03-15, under 510(k) number K171430.

Who is the listed applicant for Incontinence Treatment Device, Model LT2061?

The FDA 510(k) record lists Shenzhen Dongdixin Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Incontinence Treatment Device, Model LT2061?

The FDA product code for Incontinence Treatment Device, Model LT2061 is KPI.

Other records listing Shenzhen Dongdixin Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 10 devices →

Related Devices (Code: KPI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.