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510(k) Data Aggregation
K Number
K151693Device Name
Dr-Ho's Foot Pad Electrode
Manufacturer
DRTV ASIA LTD
Date Cleared
2015-10-09
(108 days)
Product Code
GXY
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
DRTV ASIA LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cutaneous Electrodes, "Dr-Ho's Foot Pad Electrodes", are intended to be used with legally marketed electrical stimulating devices such as transcutaneous electrical nerve stimulators or powered muscle stimulators. The cutaneous electrodes will deliver the stimulation signals generated by the stimulator to the feet which they are in contact with.
Device Description
The Dr-Ho's Foot Pad Electrode is a foot-shaped, flexible piece of conductive silicone rubber with a receptacle for a wire that connects the device with electrical stimulation devices such as transcutaneous electrical nerve stimulators (TENS) or powered muscle stimulators (PMS).
To stimulate the bottom of the foot the patient simply connects the Foot Pad to a TENS unit, places the Foot Pad onto the floor and then places the foot onto the Foot Pad for stimulation with the TENS device.
The Foot Pad Electrode has a female pin receptacle which accepts the lead wire from the stimulator. The entire Foot Pad Electrode is made up of conductive material to provide uniform current distribution when connected to a stimulator.
The devices can be used dry or wet when in contact with the skin. The entire surface (approx. 35 in') of the Foot Pad Electrode is very conductive, having a resistance of less than 7 ohms per inch. This low resistance provides low current density with uniform current distribution.
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