Cleared Traditional

MAXEMS, MODELS 1000 AND 2000

K091248 · Bio Protech, Inc. · Physical Medicine
Nov 2009
Decision
216d
Days
Class 2
Risk

About This 510(k) Submission

K091248 is an FDA 510(k) clearance for the MAXEMS, MODELS 1000 AND 2000, a Stimulator, Muscle, Powered (Class II — Special Controls, product code IPF), submitted by Bio Protech, Inc. (Dallas, US). The FDA issued a Cleared decision on November 30, 2009, 216 days after receiving the submission on April 28, 2009. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number K091248 FDA.gov
FDA Decision Cleared SESE
Date Received April 28, 2009
Decision Date November 30, 2009
Days to Decision 216 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code IPF — Stimulator, Muscle, Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5850