Cleared Special

Wireless Pain Relieve Device Model: LT5018C

K173462 · Shenzhen Dongdixin Technology Co., Ltd. · Neurology

Dec 2017

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K173462 is an FDA 510(k) clearance for the Wireless Pain Relieve Device Model: LT5018C, a Stimulator, Nerve, Transcutaneous, Over-the-counter (Class II — Special Controls, product code NUH), submitted by Shenzhen Dongdixin Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on December 8, 2017, 30 days after receiving the submission on November 8, 2017. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number	K173462 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 08, 2017
Decision Date	December 08, 2017
Days to Decision	30 days
Submission Type	Special
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	NUH — Stimulator, Nerve, Transcutaneous, Over-the-counter
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.5890
Definition	Temporary Relief Of Pain Due To Sore/aching Muscles