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510(k) Data Aggregation
K Number
K131550Device Name
HEART SYNC
Manufacturer
Date Cleared
2013-12-06
(191 days)
Product Code
Regulation Number
870.5310Why did this record match?
Applicant Name (Manufacturer) :
HEART SYNC INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Heart Sync Sterile Adult Radio Transparent Multi Function Electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a sterile, disposable device for single patient use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin. The electrode is intended for use on adult patients. When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 joule maximum). Compatible with Physio Control, Zoll, and "Anderson" adapted models of monophasic and bi-phasic defibrillators.
Device Description
These are single use, sterile, self stick defibrillator electrodes packaged in pairs. Effective electrode area = Conductive Area: 195.98 Sq.cm. They are radiotransparent. They come in three connector styles to match the specific defibrillator. The construction and materials employed are identical to the predicate. The patient contact material is a conductive adhesive hydrogel identical to the material used in the predicate devices. These pads meet the AAMI Standard ANSI/AAMI DF80:2003 and the connectors meet the FDA performance standard for touch proof ECG connectors.
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K Number
K131494Device Name
HEART SYNC
Manufacturer
Date Cleared
2013-09-16
(116 days)
Product Code
Regulation Number
870.5310Why did this record match?
Applicant Name (Manufacturer) :
HEART SYNC INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Indicated for use to treat patients in cardiopulmonary arrest who are unconscious, without a pulse and not breathing spontaneously. Heart Sync T-Cardiac Science AED pads are single use and intended to be used in conjunction with Cardiac Science automated external defibrillators (AED) to monitor and deliver defibrillation energy to the patient. The T-Cardiac Science AED pads are used on patients over 8 years of age or greater than 55 pounds. The electrodes are intended for short term use (less than 8 hours)
Device Description
These are single use. non-sterile, self-stick defibrillator electrodes packaged in pairs. Effective electrode area = 170 Sq. cm. They are Radiotranslucent. They come in an Anderson connector to match the specific defibrillator. The construction and materials employed are similar to the predicates. The patient contact material is a conductive adhesive hydrogel identical to the material used in the predicate device. These pads meet the AAMI Standard ANSI/AAMI DF80:2003 and the connectors meet the FDA performance standard for touch proof ECG connectors.
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K Number
K120536Device Name
HEART SYNC PEDIATRIC PHYSIO AED PAD
Manufacturer
Date Cleared
2012-08-06
(166 days)
Product Code
Regulation Number
870.5310Why did this record match?
Applicant Name (Manufacturer) :
HEART SYNC INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Indicated for use to treat patients in cardiopulmonary arrest who are unconscious, without a pulse and not breathing spontaneously. They should only be used by personnel who have been trained in its operation. Used to deliver lower-energy therapy to children from 1 year of age to 8 years or up to 55 Ibs (25kg). DO NOT DELAY THERAPY IF YOU ARE NOT SURE OF EXACT AGE OR WEIGHT.
Device Description
These are single use, non-sterile, self stick defibrillator electrodes packaged in pairs. Effective electrode area = Conductive Area: 92 Sq. cm. They are radiotranslucent. They come in two connector styles to match the specific defibrillator. The construction and materials employed are similar to the predicates. The patient contact material is a conductive adhesive hydrogel identical to the material used in the predicate devices. These pads meet the AAMI Standard ANSI/AAMI DF80:2003 and the connectors meet the FDA performance standard for touch proof ECG connectors.
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