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510(k) Data Aggregation
K Number
K201581Device Name
CPR BAND
Manufacturer
CREDO
Date Cleared
2021-03-06
(268 days)
Product Code
LIX
Regulation Number
870.5210Why did this record match?
Product Code :
LIX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CPR BAND is used as a guide in administering cardiopulmonary resuscitation (CPR) to a suspected sudden cardiac arrest (SCA) victim at least 8 years old.
Device Description
The CPR BAND is a small, lightweight device that uses rechargeable batteries and is worn on the wrist. This device is designed for first aid personnel trained in CPR and use of the CPR BAND. The CPR BAND (Model: CREDO-CB) provides real-time information about chest compression according to the latest CPR guideline when CPR is performed on patient who is estimated a sudden cardiac arrest (SCA). This device displays CPR feedback indicator for the chest compression depth. It guides chest compression rhythm through sound and indicates the total chest compression time and number of chest compression.
The CPR BAND is a device that provides Bluetooth function. It can transmit CPR record and confirm information on the mobile application of the smart device in order to training CPR Skill for user via checking data. In the smart device that provides the wireless communication function by receiving information provided by the CPR BAND, it can display the pressure axis angle, pressure axis average value, compression depth average value, compression rhythm average value, and chest compression graph which are not displayed on the CPR BAND.
The device provides other functions on the user's wrist while waiting without CPR. The time, step count, movement distance and calorie consumption function are displayed.
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K Number
K183348Device Name
Reusable Silicone Cover CPRmeter 2
Manufacturer
Laerdal Medical AS
Date Cleared
2018-12-17
(14 days)
Product Code
LIX
Regulation Number
870.5210Why did this record match?
Product Code :
LIX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CPRmeter 2 CPR Feedback Device is used as a guide in administering cardiopulmonary resuscitation (CPR) to a suspected sudden cardiac arrest (SCA) victim at least 8 years old.
Device Description
The CPRmeter 2 is used as a guide in administering CPR to a suspected sudden cardiac arrest (SCA) victim at least 8 years old. The housing material of the CPRmeter 2 is composed of polycarbonate. It is small, lightweight, and powered by a replaceable battery. The device is approximately 153 mm × 64 mm × 25 mm (6.0" × 2.5" × 1.0") and weighs approximately 191 g (6.7 oz) excluding batteries. The device is approximately the size and weight of a cell phone. It is intended to be placed between the responder's hands and the patient's chest during CPR. The CPRmeter 2 is intended for use by responders who have been trained in CPR and use of the CPRmeter 2. When placed on the bare chest of a suspected SCA victim, the CPRmeter 2 provides real-time feedback on CPR compressions in accordance with current CPR guidelines. It displays CPR feedback indicators for depth, rate, and release of chest compressions. It also counts the number of compressions in a series and provides notification of lack of expected CPR activity.
The Silicone Cover is an optional accessory to the CPRmeter 2 that is designed to cover the patient contacting side of the CPRmeter 2 and provide a larger patient-contact area during use. The Silicone Cover does not require a patient adhesive.
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K Number
K173886Device Name
CPRmeter 2 CPR Feedback Device
Manufacturer
Laerdal Medical AS
Date Cleared
2018-03-23
(92 days)
Product Code
LIX
Regulation Number
870.5210Why did this record match?
Product Code :
LIX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CPRmeter™ 2 CPR Feedback Device is used as a guide in administering cardiopulmonary resuscitation (CPR) to a suspected sudden cardiac arrest (SCA) victim at least 8 years old.
Device Description
The CPRmeter™ 2 is used as a guide in administering CPR to a suspected sudden cardiac arrest (SCA) victim at least 8 years old. The housing material of the CPRmeter™ 2 is composed of polycarbonate. It is small, lightweight and powered by a replaceable battery. The device is approximately 153 mm × 64 mm × 25 mm (6"× 2 ½"× 1") and weighs approximately 163 g (5.7 oz), excluding batteries. The device is approximately the size and weight of a cell phone. It is intended to be placed between the responder's hands and the patient's chest during CPR by means of a self-adhesive foam pad. The CPRmeter™ 2 is intended to be used by responders who have been trained in CPR and use of the CPRmeter™ 2. If the responder is in doubt about its appropriateness for use or the ability to use it. CPR is to be performed without using the CPRmeter™ 2 device.
When placed on the bare chest of a suspected SCA victim, the CPRmeter™ 2 provides real-time feedback on CPR compressions in accordance with current CPR guidelines. It displays CPR feedback indicators for depth, rate, and release of chest compressions. It also counts the number of compressions in a series and provides notification of lack of expected CPR activity. The CPRmeter™ 2 may be reused, provided proper cleaning procedures are performed after each patient use.
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K Number
K151702Device Name
Reusable Full Silicone Cover
Manufacturer
LAERDAL MEDICAL AS
Date Cleared
2015-08-13
(50 days)
Product Code
LIX
Regulation Number
870.5210Why did this record match?
Product Code :
LIX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CPRmeter™ is used as a guide in administering cardiopulmonary resuscitation (CPR) to a suspected sudden cardiac arrest (SCA) victim at least 8 years old.
Device Description
The Modified Cover is an optional accessory to the CPRmeter™ that is designed to cover the patient contacting side of the CPRmeter™ and provide a larger patient-contact area during use and does not require a patient adhesive. The CPRmeter™ is small, lightweight, and powered by a replaceable battery. The device is approximately 154 mm × 28 mm (6" × 2½" × 1″) and weighs approximately 227 grams (8 ounces) - approximately the size and weight of a cell phone. It is intended to be placed between the responder's hands and the patient's chest during CPR. The CPRmeter™ is intended for use by responders who have been trained in CPR and use of the CPRmeter™. The CPRmeter™ is used as a guide in administering CPR to a suspected sudden cardiac arrest (SCA) victim at least 8 years old. When placed on the bare chest of a suspected SCA victim, the CPRmeter™ provides real-time feedback on CPR compressions in accordance with current CPR guidelines. It displays CPR feedback indicators for depth, rate, and release of chest compressions. It also counts the number of compressions in a series and provides notification of lack of expected CPR activity.
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K Number
K123248Device Name
CPR RSQ ASSIST
Manufacturer
AVANTECH, INC.
Date Cleared
2013-12-10
(419 days)
Product Code
LIX
Regulation Number
870.5210Why did this record match?
Product Code :
LIX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CPR RsQ Assist is intended to assist the rescuer in performing chest compressions at the recommended American Heart Association (AHA) rate of 100 compressions/minute on a victim 8 years or older.
Device Description
The CPR RsQ Assist consists of a rigid plastic top with an integrated plastic support collar, a flexible plastic bellows filled with foam, and a removable silicone base platform. LED lights and a speaker component provide visual and audio cues, respectively, to the user during manual CPR compressions. The CPR RsQ Assist is provided non-sterile.
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K Number
K123597Device Name
TRUECPR COACHING DEVICE
Manufacturer
PHYSIO-CONTROL, INC.
Date Cleared
2013-04-17
(147 days)
Product Code
LIX
Regulation Number
870.5210Why did this record match?
Product Code :
LIX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TrueCPR device is intended to provide feedback to assist rescuers to perform cardiopulmonary resuscitation (CPR). Rescuers must be trained in CPR and use of the device. The TrueCPR device is intended for use on patients eight years of age and older.
Device Description
The TrueCPR coaching device provides rescuers with real-time feedback on chest compressions during cardiopulmonary resuscitations (CPR) in accordance with current guidelines.
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K Number
K122050Device Name
CPRMETER CPR FEEDBACK DEVICE
Manufacturer
LAERDAL MEDICAL A/S
Date Cleared
2012-10-22
(102 days)
Product Code
LIX
Regulation Number
870.5210Why did this record match?
Product Code :
LIX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CPRmeter is used as a guide in administering cardiopulmonary resuscitation (CPR) to a suspected sudden cardiac arrest (SCA) victim at least 8 years old.
Device Description
The CPRmeter™ device is small, lightweight (approximately the size and weight of a cell phone), and powered by a replaceable battery. The CPRmeter device is intended for use by responders who have been trained in CPR and use of the CPRmeter device. If in doubt about the appropriateness for use or ability to use. CPR is to be performed without using the CPRmeter device.
When attached to the bare chest of a suspected SCA victim, the CPRmeter device provides real-time feedback on CPR compressions in accordance with current CPR guidelines. It displays CPR feedback indicators for depth, rate, and release of chest compressions. It also counts the number of compressions in a series and provides notification of lack of expected CPR activity.
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K Number
K112660Device Name
POCKETCPR
Manufacturer
ZOLL MEDICAL CORP.
Date Cleared
2012-05-10
(240 days)
Product Code
LIX
Regulation Number
870.5210Why did this record match?
Product Code :
LIX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PocketCPR Intended Use: To assist users in the performance of effective CPR on a patient 8 years or older.
Device Description
Effective cardiopulmonary resuscitation (CPR), when administered quickly after the on-set of cardiac arrest, is effective at saving lives and enabling complete neurological recovery, especially when followed by early defibrillation. The PocketCPR® was developed to provide users with real-time feedback during the administration of CPR, to assist CPR instructors during class exercises, and to provide CPR students with verbal instructions and feedback for at-home practice. When the PocketCPR is turned on, the default protocol being driven by the 2010 American Heart Association's (AHA) Guidelines, reminds the user to call for help. Once placed on the patient's chest and chest compressions have begun, PocketCPR generates a metronome at the recommended rate of chest compression, gives verbal and visual feedback on the quality of CPR being delivered and reminds the user to give two breaths after every 30 compressions. Measurement of actual chest wall movement is made by a state-of-the-art accelerometer micro-chip and microprocessor performing continuous analysis.
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K Number
K092408Device Name
RHYTHM OF LIFE, MODEL R0901-05
Manufacturer
RAPID RESPONSE SOLUTIONS, LLC
Date Cleared
2009-10-14
(69 days)
Product Code
LIX
Regulation Number
870.5210Why did this record match?
Product Code :
LIX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Rhythm of Life is a visual and audio timing device assisting individuals trained in CPR to provide effective resuscitation by conforming to the guidelines promoted by the American Heart Association in the field, clinical, and hospital settings. The Rhythm of Life is also intended for use by those in an educational setting who are in the process of learning CPR.
Device Description
The Rhythm of Life by Rapid Response Solutions, LLC, is a pocket-sized metronome designed to assist both professional rescuers and trained lay rescuers in providing high quality cardiopulmonary resuscitation. This device is designed in accordance with the latest American Heart Association guidelines for CPR. The Rhythm of Life provides three distinctly different tones and visual feedback to prompt the rescuer to compress the patient's chest, ventilate the patient, and reassess the patient's condition every two minutes. The metronome will allow the rescuer to enter the type of patient that is being resuscitated along with other pertinent information, and then outputs proper resuscitation rates and ratios for that specific patient. Both professional and lay rescuers will benefit from additional guidance provided by the Rhythm of Life as it promotes adherence to the American Heart Association's guidelines and therefore improves the quality of patient care. The device is neither life supporting nor life sustaining.
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K Number
K071321Device Name
POCKETCPR
Manufacturer
BIO-DETEK, INC.
Date Cleared
2007-09-12
(125 days)
Product Code
LIX
Regulation Number
870.5210Why did this record match?
Product Code :
LIX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To assist users in the performance of effective CPR on a victim 8 years or older.
Device Description
PocketCPR™ is a device that uses voice prompts and visual indicators to assist rescuers in the performance of cardiopulmonary resuscitation (CPR). PocketCPR is designed to be used by a rescuer to perform CPR. PocketCPR provides rescuers with real-time feedback during the administration of CPR.
PocketCPR has two operating modes: Normal and Silent Operating Mode which allows the rescuer to perform CPR in any type of environmental condition. In Normal Operating Mode, PocketCPR operates with all sounds, including voice prompts and metronome beeping. In Silent Operating Mode, PocketCPR operates with visual flashing metronome and chest compression lights "only".
The PocketCPR directly measures acceleration through the use of an integrated accelerometer and The Fookers' It allocaly model is not compressing the chest at least 1.5 inches Instantal. Books are will instruct them to increase compression depth. The rate of compression is (comm), the Fooketer ( will morable non signal, encouraging the rescuer to keep pace with the prompled by the ace of a fiten 30 compressions or about 18 seconds of chest compressions, PocketCPR will instruct the rescuer to give breaths.
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