Cleared Traditional

Everyway Analog OTC TENS, model N103A/N302

K202849 · Everyway Medical Instruments Co.,Ltd · Neurology

Dec 2020

Decision

85d

Days

Class 2

Risk

About This 510(k) Submission

K202849 is an FDA 510(k) clearance for the Everyway Analog OTC TENS, model N103A/N302, 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 December 22, 2020, 85 days after receiving the submission on September 28, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number	K202849 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 28, 2020
Decision Date	December 22, 2020
Days to Decision	85 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