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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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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
1 VersaTek Datalogger Unit with Battery Pack Holder and Belt
Tekscan, Inc.
VersaTek Datalogger
In Commercial Distribution

  • B970VDL10 ()
VDL-1

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

  • B970VC10 ()
VC-1

  • Body-surface pressure mapping system
1 2-Port VersaTek Hub
Tekscan, Inc.
VersaTek
In Commercial Distribution

  • B970V2PH10 ()
V2PH-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
Standard Resolution Strideway Tile with Equilibration Files
Tekscan, Inc.
Any Standard Resolution Strideway System
In Commercial Distribution

  • B970SWTSR0 ()
SWT-SR

  • 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
High Resolution Strideway Tile with Equilibration Files
Tekscan, Inc.
Any High Resolution Strideway System
In Commercial Distribution

  • B970SWTHR0 ()
SWT-HR

  • Body-surface pressure mapping system
Includes 2 VersaTek Cuffs, 1 VersaTek 2-Port Hub, Power Supply and AC Cord, Clinical Foot Software CD with Sensor Map, Help File and PDF of System Manual, 10 ft. USB Cable, (2) 25 ft. Cuff Cables, 2 Velcro Wrist/Ankle Bands, Waist Belt, Sensor Carrying Case, System Carrying Case, and 1 Training Session (USA Only). System includes one of the following Sensor selections: (4) 9811E Sensors -or- (2) 9833E sensors.
Tekscan, Inc.
F-Socket VersaTek (2 Cuff) System
In Commercial Distribution

  • B970SV20 ()
SV2

  • Body-surface pressure mapping system
Includes 1 VersaTek Cuff, 1 VersaTek 2-Port Hub, Power Supply and AC Cord, Clinical Foot Software CD with Sensor Map, Help File and PDF of System Manual, 10 ft. USB Cable, 25 ft. Cuff Cable, Velcro Wrist/Ankle Band, Waist Belt, Sensor Carrying Case, System Carrying Case, and 1 Web-Based Training Session. System includes one of the following Sensor selections: (4) 9811E Sensors -or- (2) 9833E sensors.
Tekscan, Inc.
F-Socket VersaTek (1 Cuff) System
In Commercial Distribution

  • B970SV10 ()
SV1

  • Body-surface pressure mapping system
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