Cleared Traditional

MAX-IF1000

K100246 · Bio Protech, Inc. · Neurology
Nov 2010
Decision
301d
Days
Class 2
Risk

About This 510(k) Submission

K100246 is an FDA 510(k) clearance for the MAX-IF1000, a Interferential Current Therapy (Class II — Special Controls, product code LIH), submitted by Bio Protech, Inc. (Dallas, US). The FDA issued a Cleared decision on November 24, 2010, 301 days after receiving the submission on January 27, 2010. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number K100246 FDA.gov
FDA Decision Cleared SESE
Date Received January 27, 2010
Decision Date November 24, 2010
Days to Decision 301 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

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