Cleared Traditional

TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033)

K220283 · Hong Qiangxing (Shenzhen) Electronics Limited · Neurology

May 2022

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K220283 is an FDA 510(k) clearance for the TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033), 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 May 2, 2022, 90 days after receiving the submission on February 1, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number	K220283 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 01, 2022
Decision Date	May 02, 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