Cleared Traditional

K122112 - 2004-OC MASSAGE SYSTEM, 2008-OC MASSAGE SYSTEM (FDA 510(k) Clearance)

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

K122112 · Bio Compression Systems, Inc. · Physical Medicine device
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Apr 2013
Decision
266d
Days
Class 2
Risk

K122112 is an FDA 510(k) clearance for the 2004-OC MASSAGE SYSTEM, 2008-OC MASSAGE SYSTEM. Classified as Massager, Powered Inflatable Tube (product code IRP), Class II - Special Controls.

Submitted by Bio Compression Systems, Inc. (Toms River, US). The FDA issued a Cleared decision on April 9, 2013 after a review of 266 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 Bio Compression Systems, Inc. devices

Submission Details

510(k) Number K122112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2012
Decision Date April 09, 2013
Days to Decision 266 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
151d slower than avg
Panel avg: 115d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 149
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