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The Fitbit ECG App is a software-only mobile medical application intended for use with Fitbit wrist-wearable devices to create, record, store, transfer, and display a single channel electrocardiogram (ECG) qualitatively similar to a Lead I ECG. The Fitbit ECG App determines the presence of atrial fibrillation (AFib) or sinus rhythm on a classifiable waveform. The AF detection function is not recommended for users with other known arrhythmias.
The Fitbit ECG App is intended for over-the-counter (OTC) use. The ECG data displayed by the ECG Spot Check is
intended for informational use only. The user is not intended to interpret or take clinical action based on the device output without consultation of a qualified healthcare professional. The ECG waveform is meant to supplement rhythm classification for the purposes of discriminating AFib from normal sinus rhythm and is not intended to replace traditional methods of diagnosis or treatment. The Fitbit ECG App is not intended for use by people under 22 years old
FITBIT, INC.
FB603
In Commercial Distribution
- 00810038851983 ()
- Cardiopulmonary physiological parameter analysis software
SW, EXE, Lifeline Response Smart Phone Application, Google
Lifeline Systems Company
300000161331
Not in Commercial Distribution
- 00884838082137 ()
mSafe
- Vulnerable patient home alert system
SW, EXE, Lifeline Response Smart Phone Application, Apple
Lifeline Systems Company
300000161311
Not in Commercial Distribution
- 00884838082120 ()
mSafe
- Vulnerable patient home alert system
Optionally, the electrostimulator (SPM01M1) can require the combined use with the MySPM@Home mobile application, as accessory of the Subject device.
It allows to monitor the user and guide rehabilitation and training through specific protocols.
NCS LAB SRL
SPM01A2
In Commercial Distribution
- 08051122040933 ()
SPM01A2
- Physical therapy transcutaneous neuromuscular electrical stimulation system
ECG iPhone App (version 2.0)
APPLE INC.
Feature Version 2.x
In Commercial Distribution
- 00190199649293 ()
- Cardiopulmonary physiological parameter analysis software
ECG Watch App (version 2.0)
APPLE INC.
Feature Version 2.x
In Commercial Distribution
- 00190199649286 ()
- Cardiopulmonary physiological parameter analysis software
ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSL1
In Commercial Distribution
- 50888439686430 ()
- 10888439686432 ()
SBA11LLSL1
- Laparoscopic surgical procedure kit, non-medicated, single-use
SYSTEM,APP,AIRONE, 220 VOLT
MEDLINE INDUSTRIES, INC.
MSCAIRONE220
In Commercial Distribution
- 10080196403905 ()
MSCAIRONE220
- Alternating-pressure bed mattress overlay, reusable
ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSL2
In Commercial Distribution
- 50888439768440 ()
- 10888439768442 ()
SBA11LLSL2
- Laparoscopic surgical procedure kit, non-medicated, single-use
DreamMapper Mobile App Android (APAC)
Respironics, Inc.
DreamMapper Mobile App Android, Asia- Pacific Instance - 2
In Commercial Distribution
- 00606959057678 ()
1127960
- Self-care monitoring/reporting software