Cleared Traditional

TENS AND EMS (TENS and Muscle Stimulator) (JT8012, JT8012B)

K250053 · Shenzhen Jiantuo Electronics Co., Ltd. · Neurology

May 2025

Decision

119d

Days

Class 2

Risk

About This 510(k) Submission

K250053 is an FDA 510(k) clearance for the TENS AND EMS (TENS and Muscle Stimulator) (JT8012, JT8012B), 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 May 9, 2025, 119 days after receiving the submission on January 10, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number	K250053 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 10, 2025
Decision Date	May 09, 2025
Days to Decision	119 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