TekDAQ 200 TD-200

GUDID B970TD2000

TekDAQ 200 Wearable Sensor Data Acquisition Device

Tekscan, Inc.

Body-surface pressure mapping system Body-surface pressure mapping system Body-surface pressure mapping system Body-surface pressure mapping system Body-surface pressure mapping system Body-surface pressure mapping system Body-surface pressure mapping system Body-surface pressure mapping system Body-surface pressure mapping system Body-surface pressure mapping system Body-surface pressure mapping system

• Primary Device ID: B970TD2000
• NIH Device Record Key: 554e182f-9679-4391-a387-bdd7f2b5c5b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TekDAQ 200
• Version Model Number: TekDAQ 200
• Catalog Number: TD-200
• 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: true
• Manufacturing Date: false
• 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	B970TD2000 [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: 2024-03-11
• Device Publish Date: 2024-03-01

Devices Manufactured by Tekscan, Inc.

• B970FG2PRO0 - F-Scan GO: 2024-03-22 Includes 2 TekDAQ 200 Wi-Fi Wearable Sensor Acquisition Units, FootVIEW 10.0 Pro In-Shoe Pressure Measurement Software, 2 Velcro
• B970FG20 - F-Scan GO: 2024-03-11 Includes 2 TekDAQ 200 Wi-Fi Wearable Sensor Acquisition Units, FootVIEW 10.0 In-Shoe Pressure Measurement Software, 2 Velcro Ank
• B970TD2000 - TekDAQ 200: 2024-03-11TekDAQ 200 Wearable Sensor Data Acquisition Device
• B970TD2000 - TekDAQ 200: 2024-03-11 TekDAQ 200 Wearable Sensor Data Acquisition Device
• B97030101250 - F-Scan GO 3010 Sensor: 2023-12-07 3010, Matrix Sensor, 125psi
• B970BCE531510 - BPMS Evolution: 2020-10-22 Includes 1 Evolution Handle, BPMS Clinical Software CD with Sensor Map corresponding to Sensor 5315, Help File and PDF of System