Cleared Traditional

K003909 - PROACT 1

K003909 is an FDA 510(k) clearance for PROACT 1, manufactured by Proact Co.. The device is a Class 2 Physical Medicine device with product code IRP cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K003909 · Proact Co. · Physical Medicine device
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Jun 2001
Decision
176d
Days
Class 2
Risk

K003909 is an FDA 510(k) clearance for the PROACT 1. Classified as Massager, Powered Inflatable Tube (product code IRP), Class II - Special Controls.

Submitted by Proact Co. (Mt Pleasant, US). The FDA issued a Cleared decision on June 13, 2001 after a review of 176 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5650 - 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 Proact Co. devices

FDA 510(k) Submission Details - K003909

510(k) Number K003909 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2000
Decision Date June 13, 2001
Days to Decision 176 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
61d slower than avg
Panel avg: 115d · This submission: 176d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IRP Device Classification - Class 2, Special Controls

Product Code IRP Massager, Powered Inflatable Tube
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5650
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 - IRP Massager, Powered Inflatable Tube

All 129
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