Family Healthware™ - Family Healthware™ is a self-administered, - SANITAS, INC.

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.

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More Product Details

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

Product Characteristics

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 Details

Product Code

DRG

Product Code Name

Transmitters And Receivers, Physiological Signal, Radiofrequency

Device Record Status

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

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SANITAS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2