Cleared Traditional

K163451 - Action Trackstander models TR1816, TR1820, TR2016, and TR2020 (FDA 510(k) Clearance)

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

K163451 · Action Manufacturing, Inc. · Physical Medicine device
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Jan 2018
Decision
400d
Days
Class 2
Risk

K163451 is an FDA 510(k) clearance for the Action Trackstander models TR1816, TR1820, TR2016, and TR2020. Classified as Wheelchair, Standup (product code IPL), Class II - Special Controls.

Submitted by Action Manufacturing, Inc. (Marshall, US). The FDA issued a Cleared decision on January 12, 2018 after a review of 400 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3900 - 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. Elevated predicate reliance profile. 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 Action Manufacturing, Inc. devices

Submission Details

510(k) Number K163451 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2016
Decision Date January 12, 2018
Days to Decision 400 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
285d slower than avg
Panel avg: 115d · This submission: 400d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IPL Wheelchair, Standup
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3900
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.