Tekscan, Inc.

Address:307 WEST FIRST ST.,BOSTON,MA,02127,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Pressure Measurement, Intermittent (JFC) (9)

Premarket Exempt

Yes

Clear

VersaTek Cuff - B970VC10 Catalog Number : VC-1

Device Description : 2 VersaTek Cuffs

Device Class : 1

Duns Number: 178180246

Premarket Exempt : Yes

Product Code : JFC

Prescription Use : No

Device Count : 1

Versatek Datalogger - B970VDL10 Catalog Number : VDL-1

Device Description : 1 VersaTek Datalogger Unit with Battery Pack Holder and Belt

Device Class : 1

Duns Number: 178180246

Premarket Exempt : Yes

Product Code : JFC

Prescription Use : No

Device Count : 1

Walkway Evolution - B970VH20 Catalog Number : VH2

Device Description : Includes 2 Evolution Handles, Walkway Software CD with 5101D Map and 3 Factory E 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)

Device Class : 1

Duns Number: 178180246

Premarket Exempt : Yes

Product Code : JFC

Prescription Use : No

Device Count : 1

Walkway Evolution - B970VH30 Catalog Number : VH3

Device Description : Includes 3 Evolution Handles, (1) 4-Port Powered USB Hub, Walkway Software CD wi Includes 3 Evolution Handles, (1) 4-Port Powered USB Hub, Walkway Software CD with 5101TL Map and 3 Factory Equilibration Files, Help File and PDF of System Manual, (3) 5101 Sensors (pre-assembled into a single floor display), and 1 Training Session (USA Only)

Device Class : 1

Duns Number: 178180246

Premarket Exempt : Yes

Product Code : JFC

Prescription Use : No

Device Count : 1

Walkway Evolution - B970VH40 Catalog Number : VH4

Device Description : Includes 4 Evolution Handles, (1) 4-Port Powered USB Hub, Walkway Software CD wi 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)

Device Class : 1

Duns Number: 178180246

Premarket Exempt : Yes

Product Code : JFC

Prescription Use : No

Device Count : 1

Versatek Wireless - B970VW10 Catalog Number : VW-1

Device Description : 1 VersaTek Wireless Unit with Battery Pack Holder and Belt

Device Class : 1

Duns Number: 178180246

Premarket Exempt : Yes

Product Code : JFC

Prescription Use : No

Device Count : 1

VersaTek Wireless Datalogger - B970VWD10 Catalog Number : VWD-1

Device Description : 1 VersaTek Wireless/Datalogger Unit with Battery Pack Holder and Belt

Device Class : 1

Duns Number: 178180246

Premarket Exempt : Yes

Product Code : JFC

Prescription Use : No

Device Count : 1

HR Mat Assembly - B970ZPKGHIRESFLRFLRE0 Catalog Number : ZPKG-HIRES-FLR-FLR-E

Device Description : HR Mat Assembly: Includes sensor and platform

Device Class : 1

Duns Number: 178180246

Premarket Exempt : Yes

Product Code : JFC

Prescription Use : No

Device Count : 1

Presto-Scan Evolution - B970ZPKGPRESTOSCANEVOL0 Catalog Number : ZPKG-PRESTOSCAN-EVOLUTION

Device Description : Includes 3140 Sensor installed in Presto-Scan display with 1 built in Evolution Includes 3140 Sensor installed in Presto-Scan display with 1 built in Evolution handle, (1) 10 ft. USB-A to USB-B cable, Presto-Scan Software CD with 3140 Map, and Quick Start Guide

Device Class : 1

Duns Number: 178180246

Premarket Exempt : Yes

Product Code : JFC

Prescription Use : No

Device Count : 1

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