Cleared Traditional

K042881 - PMD-2000 INTERFERENTIAL STIMULATOR

K042881 is an FDA 510(k) clearance for PMD-2000 INTERFERENTIAL STIMULATOR, manufactured by Phoenix Medical Devices, LLC. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K042881 · Phoenix Medical Devices, LLC · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2004
Decision
30d
Days
Class 2
Risk

K042881 is an FDA 510(k) clearance for the PMD-2000 INTERFERENTIAL STIMULATOR. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Phoenix Medical Devices, LLC (Newport Beach, US). The FDA issued a Cleared decision on November 18, 2004 after a review of 30 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 - K042881

510(k) Number K042881 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2004
Decision Date November 18, 2004
Days to Decision 30 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
86d faster than avg
Panel avg: 116d · This submission: 30d
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

Entela, Inc.
NEIL E DEVINE

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 490
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K042881.
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K040849 · Cole & Associates · Oct 2004
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K032954 · Danmeter A/S · Aug 2004
BMLS03-3
K033174 · Biomedical Life Systems, Inc. · Jun 2004

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.

K042881 · PMD-2000 INTERFERENTIAL STIMULATOR
Download PDF FDA Summary Phoenix Medical Devic…