Cleared Traditional

Transcutaneous Electrical Nerve Stimulator (RJTENS-2)

K252688 · Bozhou Rongjian Medical Appliance Co., Ltd. · Neurology

Nov 2025

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K252688 is an FDA 510(k) clearance for the Transcutaneous Electrical Nerve Stimulator (RJTENS-2), a Stimulator, Nerve, Transcutaneous, Over-the-counter (Class II — Special Controls, product code NUH), submitted by Bozhou Rongjian Medical Appliance Co., Ltd. (Bozhou, CN). The FDA issued a Cleared decision on November 24, 2025, 90 days after receiving the submission on August 26, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number	K252688 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 26, 2025
Decision Date	November 24, 2025
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