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510(k) Data Aggregation
K Number
K111476Device Name
CONTOUR TECHNOLOGY MUSCLE STIMULATOR
Manufacturer
CONTOUR TECHNOLOGY
Date Cleared
2012-05-23
(362 days)
Product Code
NGX
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
CONTOUR TECHNOLOGY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Contour Technology Muscle Stimulator is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The Contour Technology Muscle Stimulator may therefore be considered a technique or method for muscle training.
The Contour Technology Muscle Stimulator Ab Belt accessory is intended for use on abdominal muscles only for strengthening and toning of abdominal muscles.
The Contour Technology Muscle Stimulator BackPad accessory is intended for use on the lower back muscles only.
Device Description
The Contour Technology Muscle Stimulator is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The Contour Technology Muscle Stimulator may therefore be considered a technique or method for muscle training for improvement of muscle tone, for the strengthening of the following muscles: upper back, lower/mid back, lower back, biceps, triceps, forearm-flexor, forearm-extensor, deltoids, abdominal, gluteus, hamstrings, quadriceps, and calves for the development of firmer muscles.
The electrical stimulation is delivered to the muscles through two channels. The output signal is monophasic, rectangular and based on a regulated voltage technology. The parameters (pulse rate, pulse duration, stimulation time, rest time) are optimized for each program. The power is supplied by 4 AAA batteries.
Pulses, transmitted by the Contour Technology Muscle Stimulator are sent to Gel Pad electrodes placed over the muscle region. The signal reaches out to the motor neuron that innervates the muscle fiber resulting in contraction of the muscle. The energy is delivered through 2-3 pairs of gel pads. Optional accessories are available to allow for hands free operation of the device when placed on the abdomen or back.
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