Cleared Traditional

TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555)

K220152 · Hong Qiangxing (Shenzhen) Electronics Limited · Neurology

Apr 2022

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K220152 is an FDA 510(k) clearance for the TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555), 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 April 19, 2022, 90 days after receiving the submission on January 19, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number	K220152 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 19, 2022
Decision Date	April 19, 2022
Days to Decision	90 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