Cleared Traditional

K032505 - AIR PRESS MASSAGER

K032505 is an FDA 510(k) clearance for AIR PRESS MASSAGER, manufactured by Telebrands Corp. The device is a Class 2 Physical Medicine device with product code IRP cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K032505 · Telebrands Corp · Physical Medicine device
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Sep 2003
Decision
42d
Days
Class 2
Risk

K032505 is an FDA 510(k) clearance for the AIR PRESS MASSAGER. Classified as Massager, Powered Inflatable Tube (product code IRP), Class II - Special Controls.

Submitted by Telebrands Corp (Washington, US). The FDA issued a Cleared decision on September 24, 2003 after a review of 42 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Telebrands Corp devices

FDA 510(k) Submission Details - K032505

510(k) Number K032505 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2003
Decision Date September 24, 2003
Days to Decision 42 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 115d · This submission: 42d
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 124
Devices cleared under the same product code (IRP) and FDA review panel - the closest regulatory comparables to K032505.
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ATLANT'S
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