Cleared Traditional

K143512 - ActiSpec Activity Monitor

K143512 is an FDA 510(k) clearance for ActiSpec Activity Monitor, manufactured by Sleep Modus, Inc.. The device is a Class 2 Physical Medicine device with product code ISD cleared through the Traditional 510(k) pathway after a 258-day FDA review.

K143512 · Sleep Modus, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K143512

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
142d slower than avg
Panel avg: 116d · This submission: 258d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ISD Device Classification - Class 2, Special Controls

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.

Regulatory Consultant

Ken Block Consulting
DIANE RUTHERFORD

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - ISD Exerciser, Measuring

All 44
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K143512 · ActiSpec Activity Monitor
Download PDF FDA Summary Sleep Modus, Inc.