Cleared Traditional

Transcutaneous Electrical Nerve Stimulator Model: ST-304

K221092 · Shenzhen Future Electronic Co., Ltd. · Neurology

Sep 2022

Decision

153d

Days

Class 2

Risk

About This 510(k) Submission

K221092 is an FDA 510(k) clearance for the Transcutaneous Electrical Nerve Stimulator Model: ST-304, a Stimulator, Nerve, Transcutaneous, Over-the-counter (Class II — Special Controls, product code NUH), submitted by Shenzhen Future Electronic Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on September 13, 2022, 153 days after receiving the submission on April 13, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number	K221092 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 13, 2022
Decision Date	September 13, 2022
Days to Decision	153 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