Cleared Traditional

K915230 - H WAVE MUSCLE STIMULATOR

K915230 is the FDA 510(k) clearance for H WAVE MUSCLE STIMULATOR by Electronic Waveform Laboratory, Inc.. It is a Class 2 Physical Medicine device (product code IPF) cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K915230 · Electronic Waveform Laboratory, Inc. · Physical Medicine device
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May 1992
Decision
170d
Days
Class 2
Risk

K915230 is an FDA 510(k) clearance for the H WAVE MUSCLE STIMULATOR. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Electronic Waveform Laboratory, Inc. (Huntington Beach, US). The FDA issued a Cleared decision on May 8, 1992 after a review of 170 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 Electronic Waveform Laboratory, Inc. devices

Submission Details

510(k) Number K915230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1991
Decision Date May 08, 1992
Days to Decision 170 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 115d · This submission: 170d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 111
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K915230.
MUSCLEMAX ELECTRICAL MUSCLE STIMULATOR
K941049 · Smith & Nephew, Inc. · May 1994
IF-II (TM), MODEL 7200
K923914 · Medical Devices, Inc. · Nov 1992
MEDTRONIC RESPOND III NEUROMUSCULAR STIMULATOR
K920436 · Medtronic Vascular · May 1992
REVISED HIGH VOLTAGE STIMULATOR INTELECT 150
K902599 · Chattanooga Group, Inc. · Oct 1990
ISOTRON 220
K900823 · Excel Tech. , Ltd. · Mar 1990
INTELECT 775MP POWERED MUSCLE STIMULATOR
K900413 · Chattanooga Group, Inc. · Mar 1990