Family Healthware™

GUDID 00860508000304

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.

SANITAS, INC.

Self-care monitoring/reporting software

• Primary Device ID: 00860508000304
• NIH Device Record Key: a2f58465-e3fe-4f3d-9df9-13f9df4b0b16
• Commercial Distribution Discontinuation: 2020-01-27
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Family Healthware™
• Version Model Number: Version 2.0 Released 20160615
• Company DUNS: 968618426
• Company Name: SANITAS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: (877) 504-6575
• Email: support@familyhealthware.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860508000304 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132173

FDA Product Code

• DRG: Transmitters And Receivers, Physiological Signal, Radiofrequency

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-28
• Device Publish Date: 2016-08-01

Devices Manufactured by SANITAS, INC.

• 00860508000304 - Family Healthware™: 2020-01-28Family 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.
• 00860508000304 - Family Healthware™: 2020-01-28 Family Healthware™ is a self-administered, interactive Web-based software tool that assesses a person's familial risk for six
• 00860508000311 - Sanitas™ Clinical Care Platform: 2020-01-28 The Sanitas™ Clinical Care Platform is a software system that collects patient physiological data (such as blood pressure and