Cleared Traditional

K080545 - ACTITRAINER

K080545 is an FDA 510(k) clearance for ACTITRAINER, manufactured by Actigraph, LLC. The device is a Class 2 Physical Medicine device with product code ISD cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K080545 · Actigraph, LLC · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2008
Decision
148d
Days
Class 2
Risk

K080545 is an FDA 510(k) clearance for the ACTITRAINER. Classified as Exerciser, Measuring (product code ISD), Class II - Special Controls.

Submitted by Actigraph, LLC (Pensacola, US). The FDA issued a Cleared decision on July 24, 2008 after a review of 148 days - within the typical 510(k) review window.

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 Actigraph, LLC devices

FDA 510(k) Submission Details - K080545

510(k) Number K080545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 115d · This submission: 148d
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 Peers - ISD Exerciser, Measuring

All 17
Devices cleared under the same product code (ISD) and FDA review panel - the closest regulatory comparables to K080545.
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