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The Fitbit Irregular Rhythm Notifications is a software-only mobile medical application that is intended to be used with compatible consumer wrist-worn products to analyze pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation (AFib) and provide a notification to the user.
The Fitbit Irregular Rhythm Notifications is intended for over-the-counter (OTC) use. It is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the Fitbit Irregular Rhythm Notifications is intended to opportunistically surface a notification of possible AFib when sufficient data are available for analysis.
These data are only captured when the user is still. Along with the user’s risk factors, the Fitbit Irregular Rhythm Notifications can be used to supplement the decision for AFib screening. The Fitbit Irregular Rhythm Notifications is not intended to replace traditional methods of diagnosis or treatment.
The Fitbit Irregular Rhythm Notifications has not been tested for and is not intended for use
in people under 22 years of age. It is also not intended for use in individuals previously
diagnosed with AFib.
FITBIT, INC.
FB604
In Commercial Distribution
- 00810038852720 ()
FB604
- Cardiopulmonary physiological parameter analysis software
3 Shelf First Aid Kit Refill with OTC Medications - Contains: Adhesive Fabric Bandages, 1" x 3", 100 ct; Adhesive Fabric Bandages, 2" x 4", 6 ct; Alcohol Wipes, 100 ct; Antacid Tablets, 100 ct; Antiseptic Spray, 4 oz; Burn Dressing, 4" x 4"; Burn Spray, 4 oz; Cold Pack, 6" x 9", 2 ct; Conforming Gauze Rolls, 2", 2 ct; Cotton Tipped Applicators, 100 ct; CPR Face Shield; Elastic Bandage Wrap, 4" x 5 yd; Extra-Strength Non-Aspirin, 100 ct; Eyewash, 4 oz bottle; Fingertip and Knuckle Fabric Bandages, 50 ct; First Aid Guide; First Aid/Burn Cream Packets, 25 ct; Hand Sanitizer Packets, 10 ct; Hema-Flex 5 x 9 Trauma Pad in 4” x 4 yd gauze, : Nitrile Exam Gloves, 12 ct; Padded Flexible Splint, 4.25" x 24"; Scissors; Sterile Eye Pads and Strips, 4 ct; Sterile Gauze Pads, 3" x 3", 10 ct; Sterile Gauze Pads, 4" x 4", 10 ct; Sterile Stretch Compress Bandage, 4"; Stretch Tourniquet, 1" x 18"; Trauma Pad, 5" x 9", 3 ct; Triangular Bandage, 40" x 40" x 56", 2 ct; Triple Antibiotic Ointment Packets, 25 ct; Triple Cut Adhesive Tape Roll, 2"; Tweezer
Acme United Corporation
90623
In Commercial Distribution
- 00092265906234 ()
90623
- First aid kit, medicated
The Propeller System includes the OTC Sensor Model 2016-M for MDI. The sensor is an accessory device intended for single-patient use to assist physicians and patients in recording and monitoring the actuations of prescribed MDI usage.
The Propeller Mobile Application records, stores, and transmits usage events from Propeller Sensors, or via manual user entry, to a remote storage system. With the Propeller Mobile Application the user can review information collected from the MDI sensor, and report and review symptoms and other information about their disease management and its impact. The user may also share their information with their caregivers, physician and healthcare providers.
The Propeller Web Application is software that, like the Propeller Mobile Application, is intended to allow users to review the collected information and characteristics of their respiratory medication(s) and its use, to capture other patient-reported information and outcomes, and to allow that information to be shared with their caregivers, physicians and healthcare providers.
When used with a prescribed MDI, the system can report on information captured during the normal course of use, such as the time between actuations that can be helpful in assessing MDI technique.
When used under the care of a physician with a prescribed MDI, or other inhaled medication, the system can be used to reduce the frequency of respiratory health symptoms and exacerbations by increasing adherence to MDI or other inhaled medications through the use of feedback such as reminders and notifications, and self-management education.
The Propeller System is intended to be used in populations from Child (>2 years) to adult.
The Propeller System can be used both indoors and outdoors; home, work, and clinical settings, as well as on aircraft.
The Propeller System may also be used in clinical trials where researchers need to know information about the use of MDI or other inhaled medication(s) by a participant.
RECIPROCAL LABS CORPORATION
Sensor Model 2016-M-L
In Commercial Distribution
- 00865528000082 ()
- Inhaler dose sensor
The Propeller System includes the OTC Sensor Model 2016-M for MDI. The sensor is an accessory device intended for single-patient use to assist physicians and patients in recording and monitoring the actuations of prescribed MDI usage.
The Propeller Mobile Application records, stores, and transmits usage events from Propeller Sensors, or via manual user entry, to a remote storage system. With the Propeller Mobile Application the user can review information collected from the MDI sensor, and report and review symptoms and other information about their disease management and its impact. The user may also share their information with their caregivers, physician and healthcare providers.
The Propeller Web Application is software that, like the Propeller Mobile Application, is intended to allow users to review the collected information and characteristics of their respiratory medication(s) and its use, to capture other patient-reported information and outcomes, and to allow that information to be shared with their caregivers, physicians and healthcare providers.
When used with a prescribed MDI, the system can report on information captured during the normal course of use, such as the time between actuations that can be helpful in assessing MDI technique.
When used under the care of a physician with a prescribed MDI, or other inhaled medication, the system can be used to reduce the frequency of respiratory health symptoms and exacerbations by increasing adherence to MDI or other inhaled medications through the use of feedback such as reminders and notifications, and self-management education.
The Propeller System is intended to be used in populations from Child (>2 years) to adult.
The Propeller System can be used both indoors and outdoors; home, work, and clinical settings, as well as on aircraft.
The Propeller System may also be used in clinical trials where researchers need to know information about the use of MDI or other inhaled medication(s) by a participant.
RECIPROCAL LABS CORPORATION
Sensor Model 2016-M-S
In Commercial Distribution
- 00865528000075 ()
- Inhaler dose sensor
The Propeller System includes the Propeller MDI Model 2 OTC Sensor. The sensor is an accessory device intended for single-patient use to assist physicians and patients in recording and monitoring the actuations of prescribed MDI usage.
The Propeller Mobile Application records, stores, and transmits usage events from Propeller Sensors, or via manual user entry, to a remote storage system. With the Propeller Mobile Application the user can review information collected from the MDI sensor, and report and review symptoms and other information about their disease management and its impact. The user may also share their information with their caregivers, physician and healthcare providers.
The Propeller Web Application is software that, like the Propeller Mobile Application, is intended to allow users to review the collected information and characteristics of their respiratory medication(s) and its use, to capture other patient-reported information and outcomes, and to allow that information to be shared with their caregivers, physicians and healthcare providers.
When used with a prescribed MDI, the system can report on information captured during the normal course of use, such as the time between actuations that can be helpful in assessing MDI technique.
When used under the care of a physician with a prescribed MDI, or other inhaled medication, the system can be used to reduce the frequency of respiratory health symptoms and exacerbations by increasing adherence to MDI or other inhaled medications through the use of feedback such as reminders and notifications, and self-management education.
The Propeller System is intended to be used in populations from Child (>2 years) to adult.
The Propeller System can be used both indoors and outdoors; home, work, and clinical settings, as well as on aircraft.
The Propeller System may also be used in clinical trials where researchers need to know information about the use of MDI or other inhaled medication(s) by a participant.
RECIPROCAL LABS CORPORATION
MDI 2 Sensor
In Commercial Distribution
- 00865528000013 ()
- Inhaler dose sensor