Cleared Traditional

Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/ K6137/ K6138/ K6139/ K6140/ K6141/ K6142/ K6143/ K6144/ K6122)

K250784 · Shenzhen Yicai Health Technology Co., Ltd. · Neurology

Aug 2025

Decision

160d

Days

Class 2

Risk

About This 510(k) Submission

K250784 is an FDA 510(k) clearance for the Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/ K6137/ K6138/ K6139/ K6140/ K6141/ K6142/ K6143/ K6144/ K6122), 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 August 21, 2025, 160 days after receiving the submission on March 14, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number	K250784 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 14, 2025
Decision Date	August 21, 2025
Days to Decision	160 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