Cleared Special

Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4

K251856 · Everyway Medical Instruments Co.,Ltd · Neurology

Nov 2025

Decision

157d

Days

Class 2

Risk

About This 510(k) Submission

K251856 is an FDA 510(k) clearance for the Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4, a Stimulator, Nerve, Transcutaneous, Over-the-counter (Class II — Special Controls, product code NUH), submitted by Everyway Medical Instruments Co.,Ltd (New Taipei City, TW). The FDA issued a Cleared decision on November 21, 2025, 157 days after receiving the submission on June 17, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number	K251856 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 17, 2025
Decision Date	November 21, 2025
Days to Decision	157 days
Submission Type	Special
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