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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 116d · 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 Consultant

Intertek Testing Services

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 538
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K031884.
ELECTRO NEUROMUSCULAR STIMULATOR, MODEL BMLS03-1
K031427 · Biomedical Life Systems, Inc. · Aug 2003
ELECTROMEDICARIN 900
K020478 · Electromedicarin, S.A. · Jul 2003
CEFAR REHAB 2 AND REHAB 2 PRO
K030403 · Cefar Medical AB · Jul 2003
PRIZM MEDICAL, INC. MICRO-Z STIMULATION SYSTEM
K024181 · Prizm Medical, Inc. · Jun 2003
CARE ETS
K023036 · Care Rehab and Orthopaedic · Jun 2003
SYS*STIM 208 AND 208A
K031017 · Mettler Electronics Corp. · May 2003

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.

K031884 · INTERFERENTIAL STIMULATOR, MODEL NETWAVE
Download PDF FDA Summary Ryan Telemedicine