Cleared Traditional

K041063 - SMARTWAVE MS 2000

K041063 is an FDA 510(k) clearance for SMARTWAVE MS 2000, manufactured by Newwave Medical, LLC. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 222-day FDA review.

K041063 · Newwave Medical, LLC · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2004
Decision
222d
Days
Class 2
Risk

K041063 is an FDA 510(k) clearance for the SMARTWAVE MS 2000. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Newwave Medical, LLC (Plano, US). The FDA issued a Cleared decision on December 1, 2004 after a review of 222 days - an extended review 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: 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.

View all Newwave Medical, LLC devices

FDA 510(k) Submission Details - K041063

510(k) Number K041063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2004
Decision Date December 01, 2004
Days to Decision 222 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
107d slower than avg
Panel avg: 115d · This submission: 222d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 225
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K041063.
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BMLS03-3
K033174 · Biomedical Life Systems, Inc. · Jun 2004
HIGH VOLTAGE PULSED STIMULATOR, MODEL BMLS02-7
K040306 · Biomedical Life Systems, Inc. · Mar 2004
ELECTRICAL MUSCLE STIMULATOR, MODELS N605 AND N607
K033544 · Everyway Medical Instruments Co.,Ltd · Dec 2003