F-Scan GO FG2PRO

GUDID B970FG2PRO0

Includes 2 TekDAQ 200 Wi-Fi Wearable Sensor Acquisition Units, FootVIEW 10.0 Pro In-Shoe Pressure Measurement Software, 2 Velcro Ankle Bands, 20 In-Shoe Sensors (model 3010-125), 4 Li-Po Battery Packs, 2 Battery Chargers, 2 USB-C to USB-A cables, Wireless Router, Quick Start Guide, System Carrying Case and 1 On-line Training Session (USA Only)

Tekscan, Inc.

Body-surface pressure mapping system

• Primary Device ID: B970FG2PRO0
• NIH Device Record Key: 42348760-2628-4d65-9e88-6cf6630da294
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: F-Scan GO
• Version Model Number: F-Scan GO System with FootVIEW Pro
• Catalog Number: FG2PRO
• Company DUNS: 178180246
• Company Name: Tekscan, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 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: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B970FG2PRO0 [Primary]

FDA Product Code

• JFC: System, Pressure Measurement, Intermittent

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: 2024-03-22
• Device Publish Date: 2024-03-14

On-Brand Devices [F-Scan GO]

• B970FG20: Includes 2 TekDAQ 200 Wi-Fi Wearable Sensor Acquisition Units, FootVIEW 10.0 In-Shoe Pressure Me
• B970FG2PRO0: Includes 2 TekDAQ 200 Wi-Fi Wearable Sensor Acquisition Units, FootVIEW 10.0 Pro In-Shoe Pressur