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Found 6 results
510(k) Data Aggregation
K Number
K083535Device Name
HEARTRAK SMART ECAT
Manufacturer
UNIVERSAL MEDICAL, INC.
Date Cleared
2008-12-15
(17 days)
Product Code
DXH
Regulation Number
870.2920Why did this record match?
Applicant Name (Manufacturer) :
UNIVERSAL MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Heartrak ECAT is a hand-held, portable, externally applied, cardiac event recorder; electrocardiograph transmitter.
Heartrak Smart ECAT is a wireless ambulatory, multi-channel, continuous ECG event recorder with embedded arrhythmia detection algorithms. Heartrak Smart ECAT registers symptomatic and asymptomatic cardiac events triggered by a patient manually or auto-triggered by embedded arrhythmia detection algorithms. Using wireless technology, Heartrak Smart ECAT, when placed within range of an RF compatible receiver, uploads recorded ECG waveform and ECG parameter data to the receiver. When data upload is complete, data can be reviewed and analyzed at a physician's office, clinic, or monitoring center.
Heartrak Smart ECAT does not deliver any energy, administer any drugs, make any diagnosis, or control a patient's life. Heartrak Smart ECAT is for prescription use only.
Device Description
Heartrak Smart ECAT is a cardiac event recorder that is used to continuously scan and capture ECG signals. Patients can use Heartrak Smart ECAT to capture ECG data both before and after they experience a cardiac symptom. Heartrak Smart ECAT can capture and automatically record asymptomatic, infrequent, or illusive arrhythmia events such as Bradycardia, and Atrial Fibrillation.
Heartrak Smart ECAT can store up to 30 days of ECG data in its memory. The physician can use a compatible wireless device to set event recording times and autotriggering parameters and then upload them to a patient's monitor.
Using wireless technology, Heartrak Smart ECAT, when placed within range (less than 10 meters) of an RF compatible receiver, uploads recorded ECG waveform and ECG parameter data to the receiver. When data upload is complete, data can be reviewed and analyzed at a physician's office, clinic, or monitoring center.
The physician is to instruct the patient on the proper use and care of the Heartrak Smart ECAT monitor. Patients should be told to contact their physician if they have any further questions.
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K Number
K071130Device Name
HEARTRAK AF
Manufacturer
UNIVERSAL MEDICAL, INC.
Date Cleared
2008-05-14
(387 days)
Product Code
DXH
Regulation Number
870.2920Why did this record match?
Applicant Name (Manufacturer) :
UNIVERSAL MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Heartrak Smart AF is a hand-held, portable, externally applied, cardiac event recorder that is intended for transtelephonic use. Patient calls a receiving center at the hospital or physician's office from the patient's home to play back the recording. Heartrak Smart AF converts electrocardiogram (ECG) signals into audio tones which are transmitted over the telephone lines.
Heartrak Smart AF does not deliver any energy, administer any drugs, or control a patient's life. Heartrak Smart AF is not a diagnostic tool and performs no diagnostic functions.
Device Description
Heartrak Smart AF is a hand-held, portable, externally applied transtelephonic cardiac event recorder device, which is intended for transtelephonic use.
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K Number
K033451Device Name
HEARTRAK SMART AT/HEARTRAK SMART2
Manufacturer
UNIVERSAL MEDICAL, INC.
Date Cleared
2004-02-05
(98 days)
Product Code
DXH
Regulation Number
870.2920Why did this record match?
Applicant Name (Manufacturer) :
UNIVERSAL MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Used as a supplement to Holter Monitoring to document infrequent/transient symptoms such as lightheadedness, chest discomfort, palpitations, pre-syncope and syncope events.
Device Description
Heartrak Smart AT/ Heartrak Smart ² is a patient-activated transtelephonic ECG loop memory monitor which records cardiac patients' symptoms. The patient calls the receiving center, hospital or physician's office from the patient's home. Heartrak Smart AT/Heartrak Smart² converts signals into audio tones which are transmitted over telephone lines. Heartrak Smart AT/Heartrak Smart" is a hand held, portable, externally applied device which is intended for transtelephonic use. Heartrak Smart AT/Heartrak Smart² does not deliver any energy, administer any drugs, or control a patient's life. Heartrak Smart AT/Heartrak Smart² is not a diagnostic tool and performs no diagnostic functions.
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K Number
K980624Device Name
CARDIOSTATION
Manufacturer
UNIVERSAL MEDICAL, INC.
Date Cleared
1998-05-11
(82 days)
Product Code
DXH
Regulation Number
870.2920Why did this record match?
Applicant Name (Manufacturer) :
UNIVERSAL MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Cardiostation is a transtelephonic cardiac monitoring station intended to provide the reception and evaluation of the ECG signal, transmitted via standard telephone lines, using commercially available transtelephonic cardiac monitoring devices. It is intended that the Cardiostation will be used by physicians and cardiac laboratories supervised by physicians.
Device Description
Cardiostation is a transtelephonic cardiac monitoring station intended to provide the reception and evaluation of the ECG signal, transmitted via standard telephone lines, using commercially available transtelephonic cardiac monitoring devices.
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K Number
K960499Device Name
HEARTRAK XL
Manufacturer
UNIVERSAL MEDICAL, INC.
Date Cleared
1996-08-06
(186 days)
Product Code
DXH
Regulation Number
870.2920Why did this record match?
Applicant Name (Manufacturer) :
UNIVERSAL MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K954495Device Name
PACETRAK PLUS
Manufacturer
UNIVERSAL MEDICAL, INC.
Date Cleared
1996-04-22
(208 days)
Product Code
DXH
Regulation Number
870.2920Why did this record match?
Applicant Name (Manufacturer) :
UNIVERSAL MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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