FDA.reportPublic FDA data

CARE INNOVATIONS LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30088501093008850109CARE INNOVATIONS LLC1Y2020-04-25950 Iron Point Rd, Suite 160 Folsom CA US 95630

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1261551848797133K131585INTEL-GE CARE INNOVATIONS QUIETCAREKMI2013-10-08
1261551118375994
1261551962801587

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KMI12013-10-08

GUDID#

Health Harmony - A Health Harmony Kit contains the components of the Health Harmony Remote Patient Monitoring system that are needed by the patient. A Health Harmony Hub Kit is for patients that do not use the Health Harmony Mobile application. (This is a viable option when the collection of vital signs alone provides adequate information for the clinician to remotely manage the patient.) The kit contains an interface hub device and any Bluetooth medical devices (e.g. a weight scale or a pulse oximeter) that have been selected by the healthcare provider for remote collection of patient vital signs.

Care Innovations, LLC

2022-09-28

Health Harmony - A Health Harmony Kit contains the components of the Health Harmony Remote Patient Monitoring system that are needed by the patient. A Health Harmony BYOD Kit is for patients that download and use the Health Harmony Mobile application on their own personal mobile device. The kit will contain any Bluetooth medical devices (e.g. a weight scale or a pulse oximeter) that have been selected by the healthcare provider for remote collection of patient vital signs.

Care Innovations, LLC

2022-09-28

Health Harmony - A Health Harmony Kit contains the components of the Health Harmony Remote Patient Monitoring system that are needed by the patient. A Health Harmony Mobile Kit contains a personal mobile device pre-loaded with Health Harmony Mobile software that has been setup for the patient. The kit will also contain any Bluetooth medical devices (e.g. a weight scale or a pulse oximeter) that have been selected by the healthcare provider for remote collection of patient vital signs.

Care Innovations, LLC

2022-09-28

Health Harmony - Health Harmony Mobile is a component of the Health Harmony Remote Patient Monitoring system. It is a software client application that runs on a personal mobile device, used by patients to easily communicate and exchange information with their healthcare provider. The Health Harmony Mobile application collects patient responses to health assessment questions and receives patient vital signs from Bluetooth-connected medical measuring devices. The Mobile application automatically and securely transmits patient information to the provider. The Health Harmony Mobile application can also display educational material and other messages received from the provider, such as reminders encouraging patients to complete a health session or to take medications as ordered. Patients can read messages and send replies to the clinician, and may also accept or a decline a video conference call initiated by their clinician, directly from the Health Harmony Mobile application. The Enterprise version of Health Harmony Mobile is pre-loaded by the manufacturer on a personal mobile device that is provided to the patient in a Health Harmony Kit.

Care Innovations, LLC

2022-10-17

Health Harmony - Health Harmony Mobile is a component of the Health Harmony Remote Patient Monitoring system. It is a software client application that runs on a personal mobile device, used by patients to easily communicate and exchange information with their healthcare provider. The Health Harmony Mobile application collects patient responses to health assessment questions and receives patient vital signs from Bluetooth-connected medical measuring devices. The Mobile application automatically and securely transmits patient information to the provider. The Health Harmony Mobile application can also display educational material and other messages received from the provider, such as reminders encouraging patients to complete a health session or to take medications as ordered. Patients can read messages and send replies to the clinician, and may also accept or a decline a video conference call initiated by their clinician, directly from the Health Harmony Mobile application. The BYOD version of Health Harmony Mobile is available for download by the patient onto their own personal mobile device.

Care Innovations, LLC

2022-10-17

Health Harmony - Health Harmony Maestro is a component of the Health Harmony Remote Patient Monitoring system. It is a web-based software application that is used by healthcare providers for clinical data management and communication with patients. The Health Harmony Maestro dashboard provides a snapshot of patient data including vital signs and answers to symptom and behavior questions. Patient responses and medical device readings are risk stratified based on customer and/or individual thresholds set by the clinician. Alerts display on the dashboard triage page by the most recent date. At a glance, the clinician is able to detect patient data that is outside of threshold settings. Beyond the dashboard, detailed information may be viewed at a patient level as indicated. Clinicians can send messages to the patient that will be displayed on the Health Harmony Mobile application. Video conferencing between the clinician and patient is also available within the Health Harmony applications.

Care Innovations, LLC

2022-10-17