Cleared Traditional

Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13

K162517 · Jkh Health Co., Ltd. · Neurology

Apr 2017

Decision

217d

Days

Class 2

Risk

About This 510(k) Submission

K162517 is an FDA 510(k) clearance for the Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13, 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 April 14, 2017, 217 days after receiving the submission on September 9, 2016. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number	K162517 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 09, 2016
Decision Date	April 14, 2017
Days to Decision	217 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