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) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 116d · 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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IPF Stimulator, Muscle, Powered

All 422
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K072795.
VEINOPLUS NEUROMUSCULAR STIMULATOR
K072252 · Ad Rem Technology Sarl · Jan 2008
FD EMS, MODEL # D-FJ30E
K063642 · Fuji Dynamics Limited · Dec 2007
SAN SHIH POWERED MUSCLE STIMULATOR, MODEL 202
K071093 · San Shih Electrical Enterprise Co., Ltd. · Dec 2007
GLOBUS GENESY 1100 STIMULATOR
K071431 · Domino S.R.L. · Sep 2007
EVERLIFE POWERED MUSCLE STIMULATOR, MODEL E-100204, E-100504, E-100509, E-100804, E-201111, E-201211, E-201311
K071320 · Everlife Medical Equipment Co., Ltd. · Aug 2007
VITALSTIM EXPERIA
K070425 · Chattanooga Group · Jun 2007

FDA 510(k) Resources - Physical Medicine

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K072795 · MODELS EMS 5.0, EMS 5.1
Download PDF FDA Summary Koalaty Products, Inc.