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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 Size Type Device Class Implantable

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3000SPORT-E-50 F-Scan Sensor
Tekscan, Inc.
3000SPORT-E-50 F-Scan Sensor
In Commercial Distribution

  • B9703000SPORTE500 ()
3000SPORT-E-50

  • Body-surface pressure mapping system
3000SPORT-E-125 F-Scan Sensor
Tekscan, Inc.
3000SPORT-E-125 F-Scan Sensor
In Commercial Distribution

  • B9703000SPORTE1250 ()
3000SPORT-E-125

  • Body-surface pressure mapping system
3000-E-S F-Scan Sensor
Tekscan, Inc.
3000-E-S F-Scan Sensor
In Commercial Distribution

  • B9703000ES0 ()
3000-E-S

  • Body-surface pressure mapping system
3000-E-50 F-Scan Sensor
Tekscan, Inc.
3000-E-50 F-Scan Sensor
In Commercial Distribution

  • B9703000E500 ()
3000-E-50

  • Body-surface pressure mapping system
3000-E-125 F-Scan Sensor
Tekscan, Inc.
3000-E-125 F-Scan Sensor
In Commercial Distribution

  • B9703000E1250 ()
3000-E-125

  • Body-surface pressure mapping system
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
2 VersaTek Cuffs
Tekscan, Inc.
VersaTek
In Commercial Distribution

  • B970VC10 ()
VC-1

  • Body-surface pressure mapping system
TekDAQ 200 Wearable Sensor Data Acquisition Device
Tekscan, Inc.
TekDAQ 200
In Commercial Distribution

  • B970TD2000 ()
TD-200

  • Body-surface pressure mapping system
Medium Resolution Strideway Tile with Equilibration Files
Tekscan, Inc.
Any Medium Resolution Strideway System
In Commercial Distribution

  • B970SWTMR0 ()
SWT-MR

  • Body-surface pressure mapping system
Includes MatScan 3150E Sensor installed in floor display with 1 VersaTek Cuff, 1 VersaTek 2-Port Hub, Power Supply and AC Cord, FootMat Software for Clinicians CD with MatScan 3150 Map, Help File and PDF of System Manual, 10 ft. USB Cable, 10 ft. Cuff Cable, and 1 Web-Based Training Session
Tekscan, Inc.
MatScan VersaTek Platform with FootMat Software for Clinicians
In Commercial Distribution

  • B970MV10 ()
MV1

  • Body-surface pressure mapping system
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