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510(k) Data Aggregation
K Number
K141919Device Name
VEINOPLUS SPORT NEUROMUSCULAR STIMULATOR
Manufacturer
AD REM TECHNOLOGY SARL
Date Cleared
2015-06-16
(336 days)
Product Code
NGX, GXY
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
AD REM TECHNOLOGY SARL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VEINOPLUS® SPORT is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.
Device Description
The VEINOPLUS® SPORT, like a number of legally marketed predicate devices is a traditional battery powered muscle stimulator. It is portable, hand-held device, equipped with one single channel intended to stimulate the calf muscles or other muscles of the body (for example thighs, arms, buttock, back, shoulder or abdomen). The VEINOPLUS® SPORT device has only one operating mode, called program, stored in the internal memory.
The output stimulus is low-voltage, low frequency with rectangular voltage waveform. The device is housed in a plastic enclosure, and it is powered by an alkaline 9V primary battery. The accessories include the output cables, battery, user manual and electrode pads. No provisions are made for AC adapters, so the device cannot be connected to line under any circumstances.
The VEINOPLUS® SPORT device is supplied with all accessories (as listed below) necessary for a safe and effective session of stimulation. Main unit, cable, the pair of electrodes, battery, lanyard and user manual are packaged in carrying case then packaged in a carton box with printed messages. Refer to the picture in Section 12 Device Description.
List of accessories:
- 1pair of electrodes VEINOPLUS® Pack. Self-adhesive. Oval shape. Size 8x13 cm. Low resistance. This includes a Hydrogel for the electrodes (Refer to Sections 19 and 23F).
- 1 conductor cable for connecting the electrodes. Approximate length (w/o plug) 135 cm.
- 1 instruction manual
- 1 9V alkaline battery
- 1 lanyard
- 1 carrying case: L22.5*W4.5*H17cm.
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