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510(k) Data Aggregation
K Number
K103738Device Name
H-WAVE
Manufacturer
Date Cleared
2011-06-01
(161 days)
Product Code
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
ELECTRONIC WAVEFORM LABORATORY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The H-Wave® is indicated for the following conditions:
1. Relaxation of muscle spasms;
2. Prevention or retardation of disuse atrophy;
3. Increasing local blood circulation;
4. Muscle re-education;
5. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and
6. Maintaining or increasing range of motion.
Device Description
The H-Wave® model H4 is a portable battery operated electrical stimulation device with two channels, two sets of lead wires, three packages of self-adhesive electrodes, and a battery charger. Each channel has a pair of buttons to select the desired frequency and a dial to control the intensity of the signal. The stimulator also is supplied with an output jack for each channel, a charging jack, timer buttons, and an LCD display. The device creates therapeutic muscle contractions at frequencies of 1-70 Hz depending on the physician instructions and patient settings.
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K Number
K081998Device Name
H-WAVE SPORT
Manufacturer
Date Cleared
2009-07-09
(360 days)
Product Code
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
ELECTRONIC WAVEFORM LABORATORY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The H-Wave Sport is intended for muscle conditioning by stimulating muscle in order to improve or facilitate muscle performance. The H-Wave Sport is not intended to be used for therapy or treatment of medical diseases or medical conditions.
Device Description
The H-Wave® Sport consists of: a portable, battery operated neuromuscular stimulator with two channels, two sets of lead wires, two packages of self-adhesive electrodes and a battery charger. The H-Wave Sport stimulator is equipped with two simple dials that increase the intensity for each channel, output jacks for each channel, and a battery level indicator.
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