Cleared Traditional

K050046 - REHABILICARE IF 3 WAVE INTERFERENTIAL STIMULATOR SYSTEM, MODEL 7110S

K050046 is an FDA 510(k) clearance for REHABILICARE IF 3 WAVE INTERFERENTIAL S..., manufactured by Compex Technologies, Inc.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K050046 · Compex Technologies, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
93d
Days
Class 2
Risk

K050046 is an FDA 510(k) clearance for the REHABILICARE IF 3 WAVE INTERFERENTIAL STIMULATOR SYSTEM, MODEL 7110S. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Compex Technologies, Inc. (New Brighton, US). The FDA issued a Cleared decision on April 13, 2005 after a review of 93 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K050046

510(k) Number K050046 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2005
Decision Date April 13, 2005
Days to Decision 93 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
23d faster than avg
Panel avg: 116d · This submission: 93d
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
DANIEL W LEHTONEN

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 K050046.
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K024258 · Bio-Medical Research, Ltd. · Mar 2005
DIAMOND MEDISTIM
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BIOMOVE 3000
K042650 · Curatronic, Ltd. · Jan 2005

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.

K050046 · REHABILICARE IF 3 WAVE INTERFERENTIAL STIMULATOR SYSTEM, MODEL 7110S
Download PDF FDA Summary Compex Technologies, …