Cleared Traditional

Electronic Pulse Stimulator

K153520 · Jkh Health Co., Ltd. · Neurology

May 2016

Decision

149d

Days

Class 2

Risk

About This 510(k) Submission

K153520 is an FDA 510(k) clearance for the Electronic Pulse Stimulator, a Stimulator, Nerve, Transcutaneous, Over-the-counter (Class II — Special Controls, product code NUH), submitted by Jkh Health Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on May 5, 2016, 149 days after receiving the submission on December 8, 2015. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number	K153520 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 08, 2015
Decision Date	May 05, 2016
Days to Decision	149 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Statement

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