HealthGuard HG-15

GUDID 00860010558508

self-service wellness kiosk designed to provide results for blood pressure, weight, and percent body fat.

Futrex Tech, Inc.

Automatic-inflation electronic sphygmomanometer, non-portable

• Primary Device ID: 00860010558508
• NIH Device Record Key: 91bf22ab-324b-46bb-80a5-58cf1bbdfe95
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HealthGuard
• Version Model Number: 15
• Catalog Number: HG-15
• Company DUNS: 080232773
• Company Name: Futrex Tech, Inc.
• Device Count: 1
• DM Exempt: true
• 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: false
• Serial Number: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860010558508 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143108

FDA Product Code

• DXN: System, Measurement, Blood-Pressure, Non-Invasive

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-28
• Device Publish Date: 2023-06-20

On-Brand Devices [HealthGuard]

• 00860010558515: Sit-Down Self Service Wellness Kiosk providing measurement of blood pressure, weight, and percen
• 00860010558508: self-service wellness kiosk designed to provide results for blood pressure, weight, and percent