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510(k) Data Aggregation
K Number
K242041Device Name
STOPWET iontophoresis apparatus (SW01)
Manufacturer
Taiwan Medical Electronics Co., Ltd.
Date Cleared
2025-04-01
(263 days)
Product Code
EGJ
Regulation Number
890.5525Why did this record match?
Product Code :
EGJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
STOPWET is a Tap Water Iontophoresis apparatus. Its intended use is to treat hyperhidrosis (excessive sweating) of the hands and feet.
Device Description
STOPWET is designed for individuals suffering from hyperhidrosis (excessive sweating) of the hands and feet. It includes a pulse current generator and two pairs of containers for performing iontophoresis therapy specifically for hyperhidrosis. Users are required to place their hands or feet inside the containers, which contain dampened absorbent pads, and adjust the amplitude of the pulse current to a comfortable level. The circuit for the pulse current is limited to the distal end of the user's hands or feet, thereby minimizing the risk of cardiac discomfort. Additionally, users have the option to treat either the left or right hand using the single-limb treatment mode or treat both hands simultaneously with the dual-limb treatment mode. STOPWET can be used either in a clinical setting or at home. STOPWET is intended for users aged 13 years and above, including teenagers and adults. For teenagers aged 13 to 21 years, it is recommended to use this apparatus under adult supervision.
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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?
Product Code :
EGJ
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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K Number
K232020Device Name
Iontophoresis Electrodes
Manufacturer
TOP-RANK Health Care Co., Ltd.
Date Cleared
2023-10-16
(101 days)
Product Code
EGJ
Regulation Number
890.5525Why did this record match?
Product Code :
EGJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Iontophoresis Electrodes are intended to be used to introduce soluble salts and other drugs into the body as an alternative to hypodermic injection.
Device Description
The proposed device is indicated for the administration of soluble salts or other drugs into the body for medical purposes. The Iontophoresis Electrodes utilize adhesive electrodes have both anode and cathode electrodes that adhere to the skin. The electrodes may either be connected by leads (wires) to a separate controller Forming a current loop. The portion of the active electrode that contacts the skin also has a drug/solution reservoir. End users saturate the reservoir with the ionic solution to be delivered. The reservoir contacts the electrode and the drug/solution is delivered to the patient transdermally.
Five models (Small, Medium, Large, Butterfly and Return Electrode) are included in this series products, and they have the same intended purposes, working theories and specifications.
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K Number
K192749Device Name
Dermadry
Manufacturer
Dermadry Laboratories inc.
Date Cleared
2020-02-10
(133 days)
Product Code
EGJ
Regulation Number
890.5525Why did this record match?
Product Code :
EGJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dermadry is a Tap Water Iontophoresis device. Its intended use is to treat hyperhidrosis (excessive sweating) of the hands, feet and underarms. Using the device in any other way than its intended purpose may be dangerous.
Device Description
The Dermadry is a tap water Iontophoresis device intended to treat hyperhidrosis of the hands, feet and underarms. It achieves its action by producing a given low level direct current (DC) level between each of the two applicable members being treated (i.e. the two feet, or the two hands, or the two underarms) for a given amount of time. The current is controlled and transmitted by a controller between two electrodes in separate water basins into which each of the hands or feet are placed, or via two electrodes within water soaked spongeous pockets that are placed in each of the underarms. It is for home use by a single patient (single patient). It is for use by prescription under the direction of a physician or clinician, and is intended for adult patients.
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K Number
K191436Device Name
Saalio
Manufacturer
Saalmann medical GmbH & Co. KG
Date Cleared
2019-10-18
(141 days)
Product Code
EGJ
Regulation Number
890.5525Why did this record match?
Product Code :
EGJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Tap water iontophoresis device intended to treat hyperhidrosis (pathological sweating) affecting hands, feet, and underarms. Any other use or usage beyond this scope is considered use and may have dangerous consequences.
Device Description
The Saalio® unit is a therapeutic device for the treatment of primary focal hyperhidrosis, i.e. excessive sweating of defined body parts. The control device is powered by an external power supply and connected to two electrodes by means of two single cables. The electrodes are brought in contact with the body parts to be treated via a conductive water passage, thus closing the electric circuit. The control device conducts direct current or pulsed direct current) through the body parts.
Depending on the body part to be treated, different electrodes are used. For the treatment of hands and feet, two generous sized silicone electrodes are placed into two travs filled with tap water. The electrodes are covered with foam inserts so as to prevent the body parts to be treated making direct contact with the electrodes. For the treatment of armpits, two smaller silicone electrodes are inserted into sponge pads which have been saturated with tap water. These are then tucked under the armpits for the duration of the treatment. It must be insured that the sponge material is always sufficiently saturated.
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K Number
K170835Device Name
Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE
Manufacturer
Hightech Development
Date Cleared
2018-06-15
(452 days)
Product Code
EGJ
Regulation Number
890.5525Why did this record match?
Product Code :
EGJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Electro Antiperspirant, Electro Antiperspirant Sensitive, and the Electro Antiperspirant ELITE are tap water iontophoresis devices intended to treat hyperhidrosis (excessive sweating) affecting hands, feet, and underarms. Any other use or usage beyond this scope is considered un-intended use and may have dangerous consequences.
Device Description
Not Found
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K Number
K170291Device Name
IontoDC
Manufacturer
SOTERIX MEDICAL,INC.
Date Cleared
2017-05-01
(90 days)
Product Code
EGJ
Regulation Number
890.5525Why did this record match?
Product Code :
EGJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
IontoDC is intended to use a direct current to introduce ions of soluble salts or other drugs into the body.
Device Description
IontoDC is a bench-top, battery powered, microcontrollercontrolled iontophoresis device that delivers direct current to a drug delivery electrode placed on the patient's skin. This current expedites the migration of ionic drug solutions through the skin into localized tissue.
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K Number
K150453Device Name
TULA Iontophoresis System with Earset
Manufacturer
ACCLARENT, INC.
Date Cleared
2015-05-20
(89 days)
Product Code
EGJ
Regulation Number
890.5525Why did this record match?
Product Code :
EGJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Iontophoresis System with Earset is indicated for the administration of drug solution, salts, or ions into the ear, including the tympanic membrane, for medical purposes.
Device Description
The Acclarent Iontophoresis System with Earset (IPSES) is a single-use device that employs electric current to transport drug solution, salts, or ions into the ear, including the tympanic membrane. The TULA Iontophoresis System consists of three components, namely an Iontophoresis Control Unit, Iontophoresis Earsets and a Return Electrode Patch. Accessories to the IPSES include a Syringe and Earset Sizers. All components of the IPSES are provided non-sterile and no sterilization is required.
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K Number
K133033Device Name
HIDREX PSP1000
Manufacturer
HIDREX GMBH
Date Cleared
2015-04-08
(559 days)
Product Code
EGJ
Regulation Number
890.5525Why did this record match?
Product Code :
EGJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This Tap-Water-Iontophoresis device is intended to treat hyperhidrosis (pathological sweating) affecting hands, feet, and underarms. Any other use or usage beyond this scope is considered use and may have dangerous consequences.
Device Description
HIDREX iontophoresis devices are primarily intended for treating hyperhidrosis (excessive sweating) of hands and/or feet. Provided the optional axillary applicators are utilized, the system can also be used for treating axillary hyperhidrosis. The system consists of a control unit, power supply/safety wall adapter, and application accessories (treatment cover towel, treatment electrode, axillary sponge cushions). The control unit includes connection-jackets for accessories, control-buttons to choose the therapy-mode, a main display, and LED indicators. The device offers both DC and pulsed current output with adjustable pulse-width.
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K Number
K132832Device Name
ACTIVAPATCH ET IONTOPHORESIS PATCH
Manufacturer
ACTIVATEK INC.
Date Cleared
2014-02-13
(156 days)
Product Code
EGJ
Regulation Number
890.5525Why did this record match?
Product Code :
EGJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Activatek ActivaPatch ET Intophoresis Patch is intended to be used for the administration of soluble salts into the body for medical purposes and as an alternative to hypodermic injection.
Device Description
The Activatek ActivaPatch ET Iontophoresis Patch consists of a self-contained, disposable single-use iontophoresis patch, instructions for use, and an alcohol prep pad containing 70% isopropyl alcohol.
The ActivaPatch ET lontophoresis Patch contains an electronic module, an Active Electrode, and a Return Electrode. These elements are incorporated under an adhesive non-woven fabric covering which adheres the device to the skin. The overall dimensions of the ActivaPatch ET are 5.7 inches (length), 3.4 inches (width), and 0.2 inches (thickness).
Principle of Operation: Iontophoresis is a process that uses an electrical field across intact skin to propel charged ions into the skin and underlying tissue. The electrodes (Active and Return) are applied directly to the skin to transit the electric field. If the ion is negatively charged, then the negative electrode is designated the Active Electrode and the positive electrode is the Return Electrode. The total dose of all ions transported through the skin is proportional to the total current passed between the electrodes. Units of iontophoresis dosages are conventionally given in terms of mAmp*min, calculated by multiplying the amount of current by the time of application of the current.
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