Cleared Traditional

Transcutaneous Electrical Nerve Stimulator (K6106)

K241119 · Shenzhen Yicai Health Technology Co., Ltd. · Neurology

Jul 2024

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K241119 is an FDA 510(k) clearance for the Transcutaneous Electrical Nerve Stimulator (K6106), a Stimulator, Nerve, Transcutaneous, Over-the-counter (Class II — Special Controls, product code NUH), submitted by Shenzhen Yicai Health Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on July 22, 2024, 90 days after receiving the submission on April 23, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number	K241119 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 23, 2024
Decision Date	July 22, 2024
Days to Decision	90 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