Search Results
Found 1 results
510(k) Data Aggregation
K Number
K140530Device Name
Electro Auricular Device
Manufacturer
NAVIGANT CONSULTING, INC.
Date Cleared
2014-10-02
(212 days)
Product Code
BWK
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
NAVIGANT CONSULTING, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EAD 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 EAD system is a battery-operated, single-use device that has a preprogrammed frequency, pulse and duration for the stimulation of auricular point nerve stimulation for pain. The device power supply connects via four (4) stainless steel wires, sheathed in a plastic over-molding, to three (3) needle arrays comprised of four (4) needles each and one (1) needle array comprised of only 1 needle.
The device is powered by one 3 Volt lithium ion battery.
The device modulates a duty cycle between 2 hours on and 2 hours at rest. The maximum performance time frame is 5 days or 120 hours (5 days X 24 hours). Weight is 4 grams including batteries. The power supply dimensions are 36 mm x 17 mm x 7 mm. The needle dimensions are 0.5 mm width x 2 mm length.
Ask a Question
Page 1 of 1