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510(k) Data Aggregation
K Number
K093327Device Name
INTCO TAB ELECTRODE
Manufacturer
SHANGHAI INTCO ELECTRODE MANUFACTURING CO., LTD.
Date Cleared
2010-05-10
(196 days)
Product Code
DRX
Regulation Number
870.2360Why did this record match?
Applicant Name (Manufacturer) :
SHANGHAI INTCO ELECTRODE MANUFACTURING CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
INTCO Tab Electrodes are designed for use with general electrocardiographic procedures when ECG monitoring is deemed necessary by a physician. Such procedures include ECG surveillance and diagnosis recording. INTCO Tab Electrodes are non-sterile and are to only be used on intact (uninjured) skin.
Device Description
INTCO Tab electrodes are composed of PET tape, Ag/AgCl or carbon conductive layer, and a conductive gel. These are configured as ten electrodes applied to a siliconized card, with 10 cards per pouch
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K Number
K041954Device Name
DISPOSABLE MONITORING ELECTRODES
Manufacturer
SHANGHAI INTCO ELECTRODE MANUFACTURING CO., LTD.
Date Cleared
2004-09-15
(57 days)
Product Code
DRX
Regulation Number
870.2360Why did this record match?
Applicant Name (Manufacturer) :
SHANGHAI INTCO ELECTRODE MANUFACTURING CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
These disposable noninvasive, hypoallergenic electrodes will be used as a conductive medium between the patient and the diagnostic equipment. Depending on the application, different sizes, shapes and a choice of eigher wet gel or solid hydrogel can be used for better results. These electrodes on be used for short-term or long-term applications, up to 3 days. This product is disposable and should only be used for single use.
Device Description
These Monitoring Electrodes are non-sterile, hypoallergenic, disposable, adhesive-backed with conductive centers, composed of materials commonly used in this application:
- First Layer: Stainless Steel snap, that works as a connection point for the diagnostic equipment.
- Second Layer: Polypropylene label substrate, used for reinforcement and a printable surface for branding.
- Third Layer: Various materials i.e., medical grade polyester fabric, polyethylene foam and paper, coated with bio-compatible adhesive.
Fourth Layer: Ag/AgCl. coated, 20% carbon filled plastic sensor.
Gel Foam Layer: Polyurethane foam. Only used for conductive wet gel.
Conductive Gel: Bio-compatible conductive solid hydrogel or wet gel
Fifth Layer: Silicone coated release liner to cover the adhesive and conductive media.
The electrodes are disposable and designed for single-patient use. They have a low profile construction that uses soft pliable and conformable materials for patient comfort. Because of the adhesive nature no extra securing materials are required to anchor the device to the patient's skin. The electrodes have one universal contact point which is a stainless steel snap. The equipment manufacturers provide the receptacle to this in the form of cither a snap lead wire or a pinch clip.
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