Search Results
Found 2 results
510(k) Data Aggregation
K Number
K160138Device Name
Adhesive Electrodes
Manufacturer
GMDASZ MANUFACTURING CO., LTD
Date Cleared
2016-08-11
(203 days)
Product Code
GXY
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
GMDASZ MANUFACTURING CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Adhesive Electrodes are intended for use as a reusable, conductive adhesive interface between the patient's skin and the marketed electrical stimulators (i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) or PGF (Pulsed Galvanic Stimulation) for transmitting electrical current. The electrode is for OTC (Over-The-Counter) or Prescription use.
Device Description
Adhesive Electrodes manufactured by GMDASZ are multi-layer reusable, flexible structures composed of laminated materials commonly used in this application:
First layer: Insulating backing material: Fabric/foam/tan fabric
Second layer: Conductive film/Carbon film coated with silver/Aluminum foil film
Third layer: Biocompatible self-adhesive conductive hydrogel
Protective liner: PET
The electrodes are designed for single-patient/multiple application use. Because of the adhesive nature of the biocompatible conductive hydrogel, no securing materials are required to secure the device to the patient's skin. The electrode is connected to the electrical stimulator by lead wire, with a standard .080" recessed female terminal with insulating outer jacket. By design, the insulated outer jacket prevents the conductive connection to earth or hazardous voltages. Wire assembly is incompliance with FDA performance standard 21 CFR Part 898.
Ask a Question
K Number
K092546Device Name
GMDASZ TENS ELECTRODES, MODELS CWN1005, DIA. 5CM, DWN2505, 5CMX5CM, CWN1007.DIA. 7CM, CWN2509,5CMX9CM
Manufacturer
GMDASZ MANUFACTURING CO., LTD
Date Cleared
2009-12-18
(121 days)
Product Code
GXY
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
GMDASZ MANUFACTURING CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The GMDASZ TENS Electrodes are intended for use as a reusable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. GMDASZ's reusable electrodes are designed and intended to be used with marketed, Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) or PGF (Pulsed Galvanic Stimulation). The electrotherapy electrodes are intended to be used to apply electrical stimulation current to the patient's skin.
Device Description
GMDASZ TENS electrodes are multi-layer reusable, flexible structures composed of laminated materials commonly used in this application (Refer to attached BOM): First layer—insulating backing material: Fabric, foam or tan fabric Second layer—Conductive plastic film Third Layer – Biocompatible self-adhesive conductive hydro gel Protective liner-PET. The electrodes are designed for single-patient/ multiple application use. Because of the adhesive nature of the biocompatible conductive hydro gel, no securing materials are required to secure the device to the patient's skin. The electrode is connected to the stimulating device by lead wire, with a standard .080" recessed female terminal with insulating outer jacket. By design, the insulated outer jacket prevents the conductive connection to earth or hazardous voltages as required in IEC60601-1 Subclause 56 3(c). Wire assembly is incompliance with FDA performance standard 21 CFR Part 898.
Ask a Question
Page 1 of 1