Cleared Traditional

K072795 - MODELS EMS 5.0, EMS 5.1

K072795 is an FDA 510(k) clearance for MODELS EMS 5.0, manufactured by Koalaty Products, Inc.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K072795 · Koalaty Products, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
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Nov 2007
Decision
57d
Days
Class 2
Risk

K072795 is an FDA 510(k) clearance for the MODELS EMS 5.0, EMS 5.1. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Koalaty Products, Inc. (Tampa, US). The FDA issued a Cleared decision on November 27, 2007 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5850 - 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 Koalaty Products, Inc. devices

FDA 510(k) Submission Details - K072795

510(k) Number K072795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2007
Decision Date November 27, 2007
Days to Decision 57 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 115d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

IPF Device Classification - Class 2, Special Controls

Product Code IPF Stimulator, Muscle, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5850
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 - IPF Stimulator, Muscle, Powered

All 193
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