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)
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.

View all Fig, LLC devices

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
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 115d · 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 105
Devices cleared under the same product code (IRP) and FDA review panel - the closest regulatory comparables to K122154.
RP Lite 760R
K163280 · Mego Afek AC , Ltd. · Jan 2017
Ballancer 505 System, Model 1201-AC
K150269 · Mego Afek AC , Ltd. · May 2015
RECOVERY PUMP 737R
K140519 · Mego Afek AC , Ltd. · Jun 2014
DSJ MASSAGER
K112479 · Mego Afek AC , Ltd. · Dec 2011
POTABLE AIR MASSAGER PUTIFINO, MODEL AM-7
K071596 · Nihon Seimitsu Sokki Co., Ltd. · Feb 2008
FLOWTRON AC200/2
K874688 · Huntleigh Technology, Inc. · Sep 1988