Cleared Traditional

K031884 - INTERFERENTIAL STIMULATOR, MODEL NETWAVE

K031884 is an FDA 510(k) clearance for INTERFERENTIAL STIMULATOR, manufactured by Ryan Telemedicine. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K031884 · Ryan Telemedicine · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2003
Decision
12d
Days
Class 2
Risk

K031884 is an FDA 510(k) clearance for the INTERFERENTIAL STIMULATOR, MODEL NETWAVE. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Ryan Telemedicine (Costa Mesa, US). The FDA issued a Cleared decision on June 30, 2003 after a review of 12 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 Ryan Telemedicine devices

FDA 510(k) Submission Details - K031884

510(k) Number K031884 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2003
Decision Date June 30, 2003
Days to Decision 12 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
103d faster than avg
Panel avg: 115d · This submission: 12d
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 236
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K031884.
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K021588 · Biomedical Life Systems, Inc. · Feb 2003