Cleared Special

K103738 - H-WAVE

K103738 is an FDA 510(k) clearance for H-WAVE, manufactured by Electronic Waveform Laboratory, Inc.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Special 510(k) pathway after a 161-day FDA review.

K103738 · Electronic Waveform Laboratory, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2011
Decision
161d
Days
Class 2
Risk

K103738 is an FDA 510(k) clearance for the H-WAVE. 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 June 1, 2011 after a review of 161 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K103738

510(k) Number K103738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2010
Decision Date June 01, 2011
Days to Decision 161 days
Submission Type Special
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 116d · This submission: 161d
Pathway characteristics
Modification to existing cleared device.

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 505
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K103738.
POWERED MUSCLE STIMULATOR
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K092202 · Eswallow USA · Feb 2011
GS 3000
K102202 · Emsi · Nov 2010
K103738 · H-WAVE
Download PDF FDA Summary Electronic Waveform L…