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510(k) Data Aggregation
K Number
K171244Device Name
Physiotrace
Manufacturer
NimbleHeart, Inc.
Date Cleared
2017-08-23
(117 days)
Product Code
DRX, MHX, MWI
Regulation Number
870.2360Why did this record match?
Applicant Name (Manufacturer) :
NimbleHeart, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Physiotrace™Smart is a telemetry device intended for physiological monitoring of men and women above 18 years of age at home, workplace, exercise facilities and alternate care settings. The Physiotrace™ Smart records single lead ECG data for up to 60 minutes during resting and exercise activities; and transmits it to a server for review by healthcare team. The Physiotrace™ Smart is indicated for use as a general patient monitor to provide physiological information as part of an occupational welfare monitoring system, for general research and performance measurement purposes, or where prescribed by a healthcare professional.
The Physiotrace™ Smart is not indicated for use on critical care patients. The Physiotrace™ Smart is not indicated for diagnosis of cardiac conditions.
Device Description
The Physiotrace™ Smart has a wearable design that can be wrapped and fastened around the torso. The device uses dry ECG electrodes and embeds an ECG acquisition unit with a Bluetooth Low Energy transmitter. A mobile application controls the data acquisition, displays the status of the device, heart rate and optionally the ECG waveform during a recording session. The mobile App also stores the ECG and the exercise session information and relays it to a cloud server for permanent storage and review by healthcare staff. The Physiotrace™ Smart is designed to be used without electrolytic gels and without adhesives that necessitate skin preparation.
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