Cleared Traditional

ActiSpec Activity Monitor

K143512 · Sleep Modus, Inc. · Physical Medicine
Aug 2015
Decision
258d
Days
Class 2
Risk

About This 510(k) Submission

K143512 is an FDA 510(k) clearance for the ActiSpec Activity Monitor, a Exerciser, Measuring (Class II — Special Controls, product code ISD), submitted by Sleep Modus, Inc. (Richardson, US). The FDA issued a Cleared decision on August 26, 2015, 258 days after receiving the submission on December 11, 2014. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5360.

Submission Details

510(k) Number K143512 FDA.gov
FDA Decision Cleared SESE
Date Received December 11, 2014
Decision Date August 26, 2015
Days to Decision 258 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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