Cleared Traditional

K080661 - MODELS TENS 7000, EMS 7500 AND TWIN STIM

K080661 is an FDA 510(k) clearance for MODELS TENS 7000, 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 14-day FDA review.

K080661 · Koalaty Products, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2008
Decision
14d
Days
Class 2
Risk

K080661 is an FDA 510(k) clearance for the MODELS TENS 7000, EMS 7500 AND TWIN STIM. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Koalaty Products, Inc. (Roswell, US). The FDA issued a Cleared decision on March 24, 2008 after a review of 14 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 - K080661

510(k) Number K080661 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2008
Decision Date March 24, 2008
Days to Decision 14 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
102d faster than avg
Panel avg: 116d · This submission: 14d
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 K080661.
SRT II MUSCLE STIMULATOR
K071677 · Therapeutic Innovations, Inc. · Jul 2008
COMBI 8 MAX
K070888 · Cec Electronica S.R.L. · Jul 2008
BIOMOVE 5000 SYSTEM
K080787 · Curatronic, Ltd. · Apr 2008
MUSCLE PAIN DEVICE (MPD)
K073361 · Stevens Proof of Concept, Inc. · Mar 2008
VEINOPLUS NEUROMUSCULAR STIMULATOR
K072252 · Ad Rem Technology Sarl · Jan 2008
FD EMS, MODEL # D-FJ30E
K063642 · Fuji Dynamics Limited · Dec 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.

K080661 · MODELS TENS 7000, EMS 7500 AND TWIN STIM
Download PDF FDA Summary Koalaty Products, Inc.