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K Number
K072252Device Name
VEINOPLUS NEUROMUSCULAR STIMULATOR
Manufacturer
ADREM TECHNOLOGY SARL
Date Cleared
2008-01-30
(170 days)
Product Code
IPF, GZJ
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
ADREM TECHNOLOGY SARL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VEINOPLUS® Neuromuscular Stimulator is indicated for the following:
In the Primary Mode of Action (PMOA) when the Operating Mode number 1 for muscle stimulation is activated, the Indications for Use are:
- · Relaxation of muscle spasms.
- · Prevention or retardation of muscle disuse atrophy.
- · Increasing local blood circulation.
- · Muscle re-education.
- · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- · Maintaining or increasing range of motion.
In the other Mode of Action (MOA), when the Operating Mode number 2 for Transcutaneous Electrical Nerve Stimulation (TENS) stimulation is activated, the Indication for Use is :
· Providing symptomatic pain relief for chronic, acute or post operative pain.
Device Description
The VEINOPLUS® Neuromuscular Stimulator is a traditional battery powered muscle stimulator and it is combined with the TENS stimulator. It is a single channel device with its Operating Modes stored in the internal memory. The VEINOPLUS® provides two separate and switchable independent Operating Modes of stimulation.
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