Cleared Traditional

Wireless Pain Relieve Device

K180331 · Shenzhen Dongdixin Technology Co., Ltd. · Neurology

Jun 2018

Decision

136d

Days

Class 2

Risk

About This 510(k) Submission

K180331 is an FDA 510(k) clearance for the Wireless Pain Relieve Device, 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 June 22, 2018, 136 days after receiving the submission on February 6, 2018. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number	K180331 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 06, 2018
Decision Date	June 22, 2018
Days to Decision	136 days
Submission Type	Traditional
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