Cleared Traditional

K143512 - ActiSpec Activity Monitor (FDA 510(k) Clearance)

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K143512 is an FDA 510(k) clearance for the ActiSpec Activity Monitor. Classified as Exerciser, Measuring (product code ISD), Class II - Special Controls.

Submitted by Sleep Modus, Inc. (Richardson, US). The FDA issued a Cleared decision on August 26, 2015 after a review of 258 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5360 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Sleep Modus, Inc. devices

Submission Details

510(k) Number K143512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
143d slower than avg
Panel avg: 115d · This submission: 258d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ISD Exerciser, Measuring
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5360
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.