Cleared Traditional

Transcutaneous Electrical Nerve Stimulator

K210223 · Top-Rank Health Care Co., Ltd. · Neurology

Dec 2021

Decision

321d

Days

Class 2

Risk

About This 510(k) Submission

K210223 is an FDA 510(k) clearance for the Transcutaneous Electrical Nerve Stimulator, a Stimulator, Nerve, Transcutaneous, Over-the-counter (Class II — Special Controls, product code NUH), submitted by Top-Rank Health Care Co., Ltd. (Shaoxing, CN). The FDA issued a Cleared decision on December 15, 2021, 321 days after receiving the submission on January 28, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number	K210223 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 28, 2021
Decision Date	December 15, 2021
Days to Decision	321 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