Cleared Traditional

Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)

K190009 · Hong Qiangxing (Shenzhen) Electronics Limited · Neurology

Dec 2019

Decision

333d

Days

Class 2

Risk

About This 510(k) Submission

K190009 is an FDA 510(k) clearance for the Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S), a Stimulator, Nerve, Transcutaneous, Over-the-counter (Class II — Special Controls, product code NUH), submitted by Hong Qiangxing (Shenzhen) Electronics Limited (Shenzhen, CN). The FDA issued a Cleared decision on December 2, 2019, 333 days after receiving the submission on January 3, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number	K190009 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 03, 2019
Decision Date	December 02, 2019
Days to Decision	333 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