Duns Number:968618426
Device Description: Family Healthware™ is a self-administered, interactive Web-based software tool that assess Family Healthware™ is a self-administered, interactive Web-based software tool that assesses a person's familial risk for six diseases (coronary heart disease, stroke, diabetes, and colorectal, breast, and ovarian cancer). It provides users with a "prevention plan" containing personalized recommendations for lifestyle changes and screening. For each person, the tool collects data about the following:+ Health behaviors (e.g., smoking and exercise);+ Screening tests (e.g., blood cholesterol and mammography);+ Health history among his or her first- and second-degree relatives.One set of algorithms in the software analyzes users' family history data and assesses their familial risk for each of the six diseases. A second set of algorithms uses the data on familial risk, health behaviors, and screening results to generate personalized prevention messages.The intended use is to utilize computerized family genomic data to increase disease risk perceptions and improve chronic disease management, thereby reducing the effects of these serious chronic disorders.
Catalog Number
-
Brand Name
Family Healthware™
Version/Model Number
Version 2.0 Released 20160615
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 27, 2020
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DRG
Product Code Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
Public Device Record Key
a2f58465-e3fe-4f3d-9df9-13f9df4b0b16
Public Version Date
January 28, 2020
Public Version Number
4
DI Record Publish Date
August 01, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 2 |