Cleared Traditional

K030998 - MEDRELIEF SE SERIES

K030998 is an FDA 510(k) clearance for MEDRELIEF SE SERIES, manufactured by Healthonics, Inc.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K030998 · Healthonics, Inc. · Physical Medicine device
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Oct 2003
Decision
193d
Days
Class 2
Risk

K030998 is an FDA 510(k) clearance for the MEDRELIEF SE SERIES, MODELS SE-50, SE-100, SE-200, SE-300. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Healthonics, Inc. (New Ellenton, US). The FDA issued a Cleared decision on October 10, 2003 after a review of 193 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 Healthonics, Inc. devices

FDA 510(k) Submission Details - K030998

510(k) Number K030998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2003
Decision Date October 10, 2003
Days to Decision 193 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
78d slower than avg
Panel avg: 115d · This submission: 193d
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 167
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K030998.
ELECTRICAL MUSCLE STIMULATOR, MODELS N605 AND N607
K033544 · Everyway Medical Instruments Co.,Ltd · Dec 2003
NEUROMUSCULAR ELECTRICAL STIMULATOR, MODEL EV-807P
K033140 · Everyway Medical Instruments Co.,Ltd · Oct 2003
AUTOSOUND 7.6 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE
K032941 · Rich-Mar Corp. · Oct 2003
ELECTRO NEUROMUSCULAR STIMULATOR, MODEL BMLS03-1
K031427 · Biomedical Life Systems, Inc. · Aug 2003
SYS*STIM 208 AND 208A
K031017 · Mettler Electronics Corp. · May 2003
ELECTRO NEUROMUSCULAR STIMULATOR, MODEL BMLS02-5
K021588 · Biomedical Life Systems, Inc. · Feb 2003