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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 VersaTek Cuffs, 1 VersaTek Wireless/Datalogger Unit with Battery Pack Holder and Belt, Power Supply and AC Cord, F-Scan Clinical Software CD with F-Scan Map, Help File, PDF of System Manual, Pre-configured wireless router, Formatted Memory Stick, Li-Ion Battery Pack, Battery Pack Charger and Battery Pack Charger Power Supply, 6.5 ft. Mini A/B USB Cable, Trigger Switch, (2) 4 ft. Cuff Cables, Elastic Take-Up Belt, Elastic Belt Extension, 2 Arm/Leg Straps, 2 Velcro Cable Ties, 2 Velcro Wrist/Ankle Bands, Sensor Carrying Case, System Carrying Case, Quick Start Guide, and 1 Training Session (USA Only). System includes one of the following Sensor selections: (20) F-Scan 3000-E, (16) 3000SPORT-E, (14) 3001-E, -or- (12) 3001SPORT-E.
Tekscan, Inc.
F-Scan VersaTek Wireless/ Datalogger System
In Commercial Distribution

  • B970FVWD20 ()
FVWD2

  • Body-surface pressure mapping system
Includes 2 VersaTek Cuffs, 1 VersaTek Wireless Unit with Battery Pack Holder and Belt, Power Supply and AC Cord, F-Scan Clinical Software CD with F-Scan Map, Help File, PDF of System Manual, Pre-configured wireless router, Li-Ion Battery Pack, Battery Pack Charger and Battery Pack Charger Power Supply, 6.5 ft. Mini A/B USB Cable, (2) 4 ft. Cuff Cables, 2 Arm/Leg Straps, 2 Velcro Cable Ties, 2 Velcro Wrist/Ankle Bands, Sensor Carrying Case, System Carrying Case, Quick Start Guide, and 1 Training Session (USA Only). System includes one of the following Sensor selections: (20) F-Scan 3000-E, (16) 3000SPORT-E, (14) 3001-E, -or- (12) 3001SPORT-E.
Tekscan, Inc.
F-Scan VersaTek Wireless System
In Commercial Distribution

  • B970FVW20 ()
FVW2

  • Body-surface pressure mapping system
Includes 1 VersaTek Cuff, 1 VersaTek 2-Port Hub, Power Supply and AC Cord, F-Scan Clinical Software CD with F-Scan Map, Help File and PDF of System Manual, 6 F-Scan 3000E Sensors, 10 ft. USB Cable, 25 ft. Cuff Cable, Velcro Wrist/Ankle Band, Waist Belt, Sensor Carrying Case, System Carrying Case, Quick Start Guide, and 1 Web-Based Training Session.
Tekscan, Inc.
F-Scan Lite VersaTek System
In Commercial Distribution

  • B970FVL10 ()
FVL1

  • Body-surface pressure mapping system
Includes 2 VersaTek Cuffs, 1 VersaTek Datalogger Unit with Battery Pack Holder and Belt, Power Supply and AC Cord, F-Scan Clinical Software CD with F-Scan Map, Help File, PDF of System Manual, Formatted Memory Stick, Li-Ion Battery Pack, Battery Pack Charger and Battery Pack Charger Power Supply, 6.5 ft. Mini A/B USB Cable, Trigger Switch, (2) 4 ft. Cuff Cables, Elastic Take-Up Belt, Elastic Belt Extension, 2 Arm/Leg Straps, 2 Velcro Cable Ties, 2 Velcro Wrist/Ankle Bands, Sensor Carrying Case, System Carrying Case, Quick Start Guide, and 1 Training Session (USA Only). System includes one of the following Sensor selections: (20) F-Scan 3000-E, (16) 3000SPORT-E, (14) 3001-E, -or- (12) 3001SPORT-E.
Tekscan, Inc.
F-Scan VersaTek Datalogger System
In Commercial Distribution

  • B970FVD20 ()
FVD2

  • Body-surface pressure mapping system
Includes 2 VersaTek Cuffs, 1 VersaTek 2-Port Hub, Power Supply and AC Cord, F-Scan Clinical Software CD with F-Scan Map, Help File and PDF of System Manual, 10 ft. USB Cable, (2) 25 ft. Cuff Cables, Waist Belt, 2 Velcro Wrist/Ankle Bands, Sensor Carrying Case, System Carrying Case, Quick Start Guide, and 1 Training Session (USA Only). System includes one of the following Sensor selections: (20) F-Scan 3000-E, (16) 3000SPORT-E, (14) 3001-E, -or- (12) 3001SPORT-E.
Tekscan, Inc.
F-Scan VersaTek System
In Commercial Distribution

  • B970FV20 ()
FV2

  • Body-surface pressure mapping system
2 F-Scan64 Cuffs
Tekscan, Inc.
F-Scan64
In Commercial Distribution

  • B970FSCAN64CUFF0 ()
FSCAN-64-CUFF

  • Body-surface pressure mapping system
Includes 2 F-Scan64 Cuffs, 1 Bluetooth Dongle, 2 Power Supply and AC Cords, F-Scan64 Software with all F-Scan64 sensor maps, 2 Velcro Cuff Straps, and F-Scan64 Sensors
Tekscan, Inc.
F-Scan64 System
In Commercial Distribution

  • B970FSCAN640 ()
F-SCAN64

  • Body-surface pressure mapping system
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.
F-Scan GO System with FootVIEW Pro
In Commercial Distribution

  • B970FG2PRO0 ()
FG2PRO

  • Body-surface pressure mapping system
Includes 2 TekDAQ 200 Wi-Fi Wearable Sensor Acquisition Units, FootVIEW 10.0 In-Shoe Pressure Measurement Software, 2 Velcro Ankle Bands, 20 In-Shoe Sensors (model 3010-125), 2 Li-Ion 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.
F-Scan GO System
In Commercial Distribution

  • B970FG20 ()
FG2

  • Body-surface pressure mapping system
1 Evolution Handle
Tekscan, Inc.
Evolution
In Commercial Distribution

  • B970EH20 ()
EH-2

  • Body-surface pressure mapping system
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