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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Class Implantable

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Includes 2 Evolution Handles, Walkway Software CD with 5101D Map and 3 Factory Equilibration Files, Help File and PDF of System Manual, (2) 5101 Sensors (pre-assembled into a single floor display), and 1 Training Session (USA Only)
Tekscan, Inc.
Very HR Walkway 2 System
In Commercial Distribution

  • B970VH20 ()
VH2

  • Body-surface pressure mapping system
Includes MobileMat 3140 Sensor installed in floor display with 1 built in Evolution handle, (1) 10 ft. USB-A to USB-B cable, FootMat Software for Researchers CD with 3140 Map, Quick Start Guide, and 1 Web-Based Training Session
Tekscan, Inc.
MobileMat Platform with FootMat Software for Researchers
In Commercial Distribution

  • B970MMATRES0 ()
MMat-RES

  • Body-surface pressure mapping system
Includes MobileMat 3140 Sensor installed in floor display with 1 built in Evolution handle, (1) 10 ft. USB-A to USB-B cable, FootMat Software for Clinicians CD with 3140 Map, Quick Start Guide, and 1 Web-Based Training Session
Tekscan, Inc.
MobileMat Platform FootMat with Software for Clinicians
In Commercial Distribution

  • B970MMATCLINICAL0 ()
MMat-CLINICAL

  • Body-surface pressure mapping system
Includes 1 MatScan 3150 Sensor installed in floor display with 1 Evolution Handle, FootMat Software for Researchers CD with MatScan 3150 Sensor Map, Help File and PDF of System Manual, Quick Start Guide, and 1 Web-Based Training Session
Tekscan, Inc.
MatScan Evolution Platform with FootMat Software for Researchers
In Commercial Distribution

  • B970ME1RES0 ()
ME1-RES

  • Body-surface pressure mapping system
Includes 1 MatScan 3150 Sensor installed in floor display with 1 Evolution Handle, FootMat Software for Clinicians CD with MatScan 3150 Sensor Map, Help File and PDF of System Manual, Quick Start Guide, and 1 Web-Based Training Session
Tekscan, Inc.
MatScan Evolution Platform with FootMat Software for Clinicians
In Commercial Distribution

  • B970ME10 ()
ME1

  • Body-surface pressure mapping system
Includes 1 Evolution Handle, BPMS Clinical Software CD with 5400N Sensor Map, Help File and PDF of System Manual, System Carrying Case, Sensor Carrying Case, (1) 5400N Sensor with Sensor Cover, and 1 Web-Based Training Session (USA Only)
Tekscan, Inc.
BPMS 1 System (5400N Sensors)
In Commercial Distribution

  • B970BCE540010 ()
BCE5400-1

  • Body-surface pressure mapping system
Includes 1 Evolution Handle, BPMS Clinical Software CD with 5350 Sensor Map, Help File and PDF of System Manual, System Carrying Case, Sensor Carrying Case, (2) 5350 Sensors with Sensor Cover and 1 Web-Based Training Session (USA Only)
Tekscan, Inc.
BPMS 1 System (5350 Sensors)
In Commercial Distribution

  • B970BCE535010 ()
BCE5350-1

  • Body-surface pressure mapping system
Includes 1 Evolution Handle, BPMS Clinical Software CD with Sensor Map corresponding to Sensor 5330, Help File and PDF of System Manual, (1) 5330 Sensor, System Carrying Case, Sensor Carrying Case, and 1 Web-Based Training Session (USA Only)
Tekscan, Inc.
BPMS 1 System (5330 Sensors)
In Commercial Distribution

  • B970BCE533010 ()
BCE5330-1

  • Body-surface pressure mapping system
Includes 1 Evolution Handle, BPMS Clinical Software CD with Sensor Map corresponding to Sensor 5315, Help File and PDF of System Manual, System Carrying Case, Sensor Carrying Case, (2) 5315 Sensors with Sensor Cover, and 1 Web-Based Training Session (USA Only)
Tekscan, Inc.
BPMS 1 System (5315 Sensors)
In Commercial Distribution

  • B970BCE531510 ()
BCE5315-1

  • Body-surface pressure mapping system
Includes 4 Evolution Handles, (1) 4-Port Powered USB Hub, Walkway Software CD with 5101QL Map and 3 Factory Equilibration Files, Help File and PDF of System Manual, (4) 5101 Sensors (pre-assembled into a single floor display), and 1 Training Session (USA Only)
Tekscan, Inc.
Very HR Walkway 4 System
In Commercial Distribution

  • B970VH40 ()
VH4

  • Body-surface pressure mapping system
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