Cleared Traditional

K163451 - Action Trackstander models TR1816, TR1820, TR2016, and TR2020

K163451 is an FDA 510(k) clearance for Action Trackstander models TR1816, manufactured by Action Manufacturing, Inc.. The device is a Class 2 Physical Medicine device with product code IPL cleared through the Traditional 510(k) pathway after a 400-day FDA review.

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

FDA 510(k) Submission Details - K163451

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
284d slower than avg
Panel avg: 116d · This submission: 400d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IPL Device Classification - Class 2, Special Controls

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.

Regulatory Peers - IPL Wheelchair, Standup

All 40
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