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510(k) Data Aggregation
K Number
K171798Device Name
Silverwear Silver Pro Garment Device
Manufacturer
Media Plus, LLC
Date Cleared
2018-06-01
(350 days)
Product Code
GXY
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
Media Plus, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Silverwear SilverPro Series Conductive Garments are cutaneous electrodes to be used with legally marketed TENS or NMES devices. The knitted garment electrodes are non-sterile reusable OTC conductive garments that are intended to deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact. These body parts can include hand (glove), wrist (sleeve), elbow or arm (sleeve), knee high stockings, ankle (sleeve), back band, and shoulder band.
Device Description
The Silverwear SilverPro garment electrodes are conductive garments that are made from material which is knitted from primarily nylon yarn with minor amounts of lycra, spandex to achieve a stretch fabric for a snug garment fit polyester for tactile qualities and polyester sheathed carbon yarn and pure silver coated nylon fibers to provide conductivity. The knitting follows standard knitting procedures with the conductive knitted material being fabricated into wearable electrode garments which are provided in multiple sizes of various garment configurations including; gloves, bands, socks, and sleeves. The stretch characteristics of the material provide sufficient elasticity to ensure firm surface contact with the skin. The design of the devices is such that they can be used skin by reversing the surface contacting the skin. The entire surface of the garment electrode is very conductive having a resistance of less than 5 ohms per inch. This provides low current density with uniform current distribution to enable efficient use of these garment electrodes for use in TENS (transcutaneous electrical nerve stimulators) and NMES (powered muscle stimulator devices). The Silverwear SilverPro garment electrodes are non- sterile external devices which are designed for single patient, for multiple uses and are intended for OTC use with FDA Cleared TENS and NMES class II devices.
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