Cleared Traditional

ACTITRAINER

K080545 · Actigraph, LLC · Physical Medicine
Jul 2008
Decision
148d
Days
Class 2
Risk

About This 510(k) Submission

K080545 is an FDA 510(k) clearance for the ACTITRAINER, a Exerciser, Measuring (Class II — Special Controls, product code ISD), submitted by Actigraph, LLC (Pensacola, US). The FDA issued a Cleared decision on July 24, 2008, 148 days after receiving the submission on February 27, 2008. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5360.

Submission Details

510(k) Number K080545 FDA.gov
FDA Decision Cleared SESE
Date Received February 27, 2008
Decision Date July 24, 2008
Days to Decision 148 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code ISD — Exerciser, Measuring
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5360

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