Cleared Traditional

K071596 - POTABLE AIR MASSAGER PUTIFINO, MODEL AM-7

K071596 is an FDA 510(k) clearance for POTABLE AIR MASSAGER PUTIFINO, manufactured by Nihon Seimitsu Sokki Co., Ltd.. The device is a Class 2 Physical Medicine device with product code IRP cleared through the Traditional 510(k) pathway after a 248-day FDA review.

K071596 · Nihon Seimitsu Sokki Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2008
Decision
248d
Days
Class 2
Risk

K071596 is an FDA 510(k) clearance for the POTABLE AIR MASSAGER PUTIFINO, MODEL AM-7. Classified as Massager, Powered Inflatable Tube (product code IRP), Class II - Special Controls.

Submitted by Nihon Seimitsu Sokki Co., Ltd. (Tachikawa-Shi, Tokyo, JP). The FDA issued a Cleared decision on February 15, 2008 after a review of 248 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.

FDA 510(k) Submission Details - K071596

510(k) Number K071596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2007
Decision Date February 15, 2008
Days to Decision 248 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
132d slower than avg
Panel avg: 116d · This submission: 248d
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 157
Devices cleared under the same product code (IRP) and FDA review panel - the closest regulatory comparables to K071596.
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COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM, MODEL WHF-314 (POWER-Q1000)
K080134 · Wonjin Mulsan Co., Ltd. · Jan 2009
GAME READY CLASSIC SYSTEM, MODEL 550550
K072620 · Coolsystems, Inc. · Oct 2007
GAME READY PROFESSIONAL THERAPY SYSTEM, MODEL 550100, GAME READY PRE-PROGRAMMED PROFESSIONAL THERAPY SYSTEM
K071050 · Coolsystems, Inc. · Jun 2007
WELLNESS/JOLIVETE
K040905 · Tohkai Precision Ind. , Ltd. · Feb 2005
K071596 · POTABLE AIR MASSAGER PUTIFINO, MODEL AM-7
Download PDF FDA Summary Nihon Seimitsu Sokki …