Cleared Traditional

Everyway Analog OTC TENS

K222488 · Everyway Medical Instruments Co.,Ltd · Neurology

Nov 2022

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K222488 is an FDA 510(k) clearance for the Everyway Analog OTC TENS, a Stimulator, Nerve, Transcutaneous, Over-the-counter (Class II — Special Controls, product code NUH), submitted by Everyway Medical Instruments Co.,Ltd (Shenkeng District, New Taipei City, TW). The FDA issued a Cleared decision on November 15, 2022, 90 days after receiving the submission on August 17, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number	K222488 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 17, 2022
Decision Date	November 15, 2022
Days to Decision	90 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