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510(k) Data Aggregation
K Number
K161458Device Name
Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep Care
Manufacturer
Indiba USA Inc.
Date Cleared
2016-10-03
(130 days)
Product Code
PBX
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Indiba USA Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Indiba Diathermia Radiofrequency Devices are intended to provide topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions such as: relief of pain, muscle spasms, increase in local circulation.
The massage device provided is intended to provide a temporary reduction in the appearance of cellulite.
Device Description
The Indiba Diathermia Radiofrequency Device is a therapeutic device for deep, non-invasive diathermy. The device consists of a console which generates a radiofrequency current which is delivered to the patient, in monopolar form, through two different types of electrodes: stainless steel conductive resistive electrodes, and thin-layer insulated capacitive electrodes. The electrodes are inserted into a handle/handpiece, one handle for each kind of electrode, and the handle is connected to the console by means of a 2-metre cable.
In resistive mode the system delivers a high-frequency current of 448 kHz directly to the patient's skin surface. In capacitive mode, the electrode coating creates a layer between the electrode and the human tissue, forming a capacitor that allows a high-frequency current to pass. The high frequency current ranges between 400 kHz and 449 kHz and is automatically tuned by the equipment according to the patient's impedance. Current returns through the neutral return electrode. The Indiba Diathermia Radiofrequency Device is provided with an electroconductive media which is applied to the patients' skin prior to each treatment session.
The RF energy generates a heating profile that produces a moderate temperature rise in the subcutaneous tissue.
The temperature on the skin is measured using a separate IR (Infra-red) thermometer and there is an integrated massage device that can be used to massage the skin during cellulite treatment.
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