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510(k) Data Aggregation
K Number
K170391Device Name
ANSiStim-PP
Manufacturer
DyAnsys Inc
Date Cleared
2017-03-09
(29 days)
Product Code
BWK
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
DyAnsys Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ANSiStim-PP is an electro-acupuncture device for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
Device Description
The ANSiStim®-PP is a wearable, battery-operated device that is designed to administer continuous low-level electrical pulses to the ear over four days / 96 hours from the time of activation of the device. The electrical pulse from the device will be delivered to the stimulation point on the ear through a set of wire assembly and Stimulation needles. Three zinc air batteries with 1.4 V each provides the required stimulation energy for a maximum of 96 hours. There are three Stimulation needles and one ground electrode - which constitute of a needle and lead/ wire with the snap-fit ring. The stimulation needles are inserted at three specific points, which have the ability to stimulate the auricular cranial nerves. The ground electrode is inserted at one specific point (constant in all treatments) which forms the functional earthing to the device is also provided with a bottom ground.
There are three options available for using the ground terminal in the device. Either the ground electrode or the bottom ground can be used. Or both the ground electrode and bottom ground can be used together.
This constant current source guarantees equivalent stimulation energy regardless of the individual impedance of the skin. The treatment period varies based on the severity of the pain in the individual.
The stimulation pattern consists of 1 Hz single pulses with square waveform. The current direction is inverted every second pulse, which is intended to avoid polarization effects. To minimize the risk of adaption or tolerance to the electrical stimulation is applied for 3 hours, followed by a pause of 3 hours.
A 3-pin connector is provided, which is used to check the output voltage of the device once it is activated and before applying to the patient with any one of the voltage measuring devices available in the market with the appropriate regulatory compliance.
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