Cleared Traditional

K000655 - PPCID- PNEUMATIC PERIPHERAL CIRCULATION IMPROVEMENT (FOOTREST) DEVICE

K000655 is an FDA 510(k) clearance for PPCID- PNEUMATIC PERIPHERAL CIRCULATION..., manufactured by Ahava Stein. The device is a Class 2 Physical Medicine device with product code IRP cleared through the Traditional 510(k) pathway after a 392-day FDA review.

K000655 · Ahava Stein · Physical Medicine device
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Mar 2001
Decision
392d
Days
Class 2
Risk

K000655 is an FDA 510(k) clearance for the PPCID- PNEUMATIC PERIPHERAL CIRCULATION IMPROVEMENT (FOOTREST) DEVICE. Classified as Massager, Powered Inflatable Tube (product code IRP), Class II - Special Controls.

Submitted by Ahava Stein (Ginot Shomron, 44853, IL). The FDA issued a Cleared decision on March 26, 2001 after a review of 392 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K000655

510(k) Number K000655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2000
Decision Date March 26, 2001
Days to Decision 392 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
276d slower than avg
Panel avg: 116d · This submission: 392d
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 K000655.
RELAXOR PERFECT TOUCH AIR MASSAGING SYSTEM
K030437 · Salton, Inc. · Apr 2003
BIOTOUCH MASSAGE THERAPY SYSTEM
K013061 · Tactile Systems Technology, Inc. · Jul 2002
PROACT 1
K003909 · Proact Co. · Jun 2001
SLENDAIR 4000 COMPRESSION SYSTEM
K994057 · Medical Compression Systems (Dbn) , Ltd. · Mar 2000
INTERMITTENT COMPRESSION BOOT FOR OTC
K991921 · Eischoco, Inc. · Aug 1999
ATLANT'S
K974395 · Grad-Line Corp. · Oct 1998
K000655 · PPCID- PNEUMATIC PERIPHERAL CIRCULATION IMPROVEMENT (FOOTREST) DEVICE
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