Cleared Traditional

Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300

K202470 · Everyway Medical Instruments Co.,Ltd · Neurology

Nov 2020

Decision

89d

Days

Class 2

Risk

About This 510(k) Submission

K202470 is an FDA 510(k) clearance for the Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300, 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, CN). The FDA issued a Cleared decision on November 25, 2020, 89 days after receiving the submission on August 28, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number	K202470 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 28, 2020
Decision Date	November 25, 2020
Days to Decision	89 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