Cleared Traditional

TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)

K253305 · Shenzhen Jiantuo Electronics Co., Ltd. · Neurology

Dec 2025

Decision

93d

Days

Class 2

Risk

About This 510(k) Submission

K253305 is an FDA 510(k) clearance for the TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034), a Stimulator, Nerve, Transcutaneous, Over-the-counter (Class II — Special Controls, product code NUH), submitted by Shenzhen Jiantuo Electronics Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on December 31, 2025, 93 days after receiving the submission on September 29, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number	K253305 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 29, 2025
Decision Date	December 31, 2025
Days to Decision	93 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