Cleared Traditional

EVERYWAY INTERFERNTIAL STIMULATOR, MODEL IF-908

K110509 · Everyway Medical Instruments Co.,Ltd · Neurology
Jun 2011
Decision
118d
Days
Class 2
Risk

About This 510(k) Submission

K110509 is an FDA 510(k) clearance for the EVERYWAY INTERFERNTIAL STIMULATOR, MODEL IF-908, a Interferential Current Therapy (Class II — Special Controls, product code LIH), submitted by Everyway Medical Instruments Co.,Ltd (Roswell, US). The FDA issued a Cleared decision on June 20, 2011, 118 days after receiving the submission on February 22, 2011. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number K110509 FDA.gov
FDA Decision Cleared SESE
Date Received February 22, 2011
Decision Date June 20, 2011
Days to Decision 118 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code LIH — Interferential Current Therapy
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5890