Cleared Traditional

TENS&EMS (HZ9151B, HZ9151C, HZ9151D)

K253740 · Hong Qiangxing (Shenzhen) Electronics Limited · Neurology

Dec 2025

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K253740 is an FDA 510(k) clearance for the TENS&EMS (HZ9151B, HZ9151C, HZ9151D), a Stimulator, Nerve, Transcutaneous, Over-the-counter (Class II — Special Controls, product code NUH), submitted by Hong Qiangxing (Shenzhen) Electronics Limited (Shenzhen, CN). The FDA issued a Cleared decision on December 23, 2025, 29 days after receiving the submission on November 24, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number	K253740 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 24, 2025
Decision Date	December 23, 2025
Days to Decision	29 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