Cleared Special

StimPlus Patch, StimPlus Patch, StimPlus Patch

K200561 · Jkh Health Co., Ltd. · Neurology

Jul 2020

Decision

119d

Days

Class 2

Risk

About This 510(k) Submission

K200561 is an FDA 510(k) clearance for the StimPlus Patch, StimPlus Patch, StimPlus Patch, 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 July 1, 2020, 119 days after receiving the submission on March 4, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number	K200561 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 04, 2020
Decision Date	July 01, 2020
Days to Decision	119 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