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510(k) Data Aggregation
K Number
K241267Device Name
Hidroxa SE30
Manufacturer
Hidroxa Medical AB
Date Cleared
2024-10-17
(164 days)
Product Code
EGJ
Regulation Number
890.5525Why did this record match?
Applicant Name (Manufacturer) :
Hidroxa Medical AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of this tap-water iontophoresis device is to treat patients with hyperhidrosis (excessive sweating) of the palms, feet, armpits.
Device Description
The medical Hidroxa SE30 is a tap water iontophoresis to treat focal hyperhidrosis to treat focal hyperhidrosis is considered state of the art and is one of the first line of treatments in many country's Clinical guidelines.
The Hidroxa SE30 iontophoresis device consists of two electrodes (Aluminium) which are connected to the main unit with one electrode cable each. The electrodes come in two different types. The small electrodes are used to treat hyperhidrosis of the armpits. The electrodes are covered by sponges pockets (cellulose), soaked in tap water and placed directly in the armain unit, one AC-adapter and two electrode cables. The large electrodes are used to treat hyperhidrosis of the palms and feet. Tap water is poured into two water bins and one large electrode is placed in each water bin. One towel (cotton) is placed over each of the electrodes to cover them. One hand/foot is then placed on each towel covered electrode. Treatment is performed by the main unit driving an electrical current through the intected treatment areas indirectly through the water in two water bins or via the electrodes in the alectrodes themselves will never be in direct contact with the skin, but instead cover the sponge pockets/towels during treatment. The main unit is powered from the wall mains using an AC adapter.
The treatment consists of two phases; 1. The initial phase consists of daily to every third day treatments (20 minutes) until desired results are seen. (Ordinary 12 treatments). When the desired results are achieved, switching to the maintenance schedule means treatments (ordinary 20 minutes) 1-3 three times per week to maintain the results.
This treatment can be done at home by the patient themselves or at a clinic with the aid of a medical professional.
The mechanism of action for tap water iontophoresis as a treatment of hyperhidrosis is not fully understood. Several hypotheses have been proposed in different medical papers. One of them is that the ions in the water form a mechanical blockage that prevents sweat from coming out of the sweat glands, resulting in less sweating. Another theory is that the treatment affects the nerve impulses connected to the sweat glands which leads to reduced activity in the glands and thus reduced or seized sweat production. Recent studies suggest that iontophoresis increases the threshold value in the nerve cells so that more stimuli is required for an action potential, a signal to the sweat gland, to arise. lontophoresis is generally considered to be a safe and effective treatment for hyperhidrosis in many cases but not a cure. Regular maintenance treatments are needed to maintain the achieved results.
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