Cleared Traditional

K122154 - POWERPLAY MUSCLE MASSAGER

K122154 is an FDA 510(k) clearance for POWERPLAY MUSCLE MASSAGER, manufactured by Fig, LLC. The device is a Class 2 Physical Medicine device with product code IRP cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K122154 · Fig, LLC · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2012
Decision
124d
Days
Class 2
Risk

K122154 is an FDA 510(k) clearance for the POWERPLAY MUSCLE MASSAGER. Classified as Massager, Powered Inflatable Tube (product code IRP), Class II - Special Controls.

Submitted by Fig, LLC (Orange Park, US). The FDA issued a Cleared decision on November 21, 2012 after a review of 124 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K122154

510(k) Number K122154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2012
Decision Date November 21, 2012
Days to Decision 124 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 116d · This submission: 124d
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 153
Devices cleared under the same product code (IRP) and FDA review panel - the closest regulatory comparables to K122154.
COMPRESSIBLE LIMB SLEEVE SYSTEM
K130385 · Maxstar Industrial Co., Ltd. · Feb 2014
2004-OC MASSAGE SYSTEM, 2008-OC MASSAGE SYSTEM
K122112 · Bio Compression Systems, Inc. · Apr 2013
PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK
K123829 · Portable Therapeutix, LLC · Apr 2013
COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM
K120166 · Won Industrial Co. · May 2012
COMPRESSIBLE LIMB THERAPY SYSTEM
K113275 · Wonjin Mulsan Co., Ltd. · Feb 2012
COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM
K112441 · Daesung Maref Co., Ltd. · Jan 2012
K122154 · POWERPLAY MUSCLE MASSAGER
Download PDF FDA Summary Fig, LLC