FDA.reportPublic FDA data

CONFORMat VersaTek Wireless

Primary DI
B970CVW20
Brand
CONFORMat VersaTek Wireless
Company
Tekscan, Inc.
Model
CONFORMat 2 VersaTek Wireless System
Catalog number
CVW2
Device description
Includes 2 VersaTek Cuffs, 1 VersaTek Wireless Unit with Battery Pack Holder and Belt, Power Supply and AC Cord, Line Filter, CONFORMat Clinical Software CD with CONFORMat and CONFORMat Dual Maps, Help File, PDF of System Manual and Wireless software features, Pre-configured wireless router, (2) 5330E Sensors, Li-Ion Battery Pack, Battery Pack Charger and Battery Pack Charger Power Supply, 6.5 ft. Mini USB Cable, (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 Tube, System Carrying Case, Quick Start Guide, and 1 Training Session (USA Only)
Published
2020-11-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JFCSystem, Pressure Measurement, Intermittent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JFCSystem, Pressure Measurement, IntermittentPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B970CVW20PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Body-surface pressure mapping systemAn assembly of electronic devices intended to be used to measure the contact pressure between the body surface and a pressure-sensing pad to provide a map of compression forces during planning of/preparation for personal mobility device use or body support device use by a patient. Described as pressure mapping technology (PMT), it includes a sensor pad and a dedicated computer/software for data analysis, and is typically used to customize the shape of a wheelchair seating cushion to reduce the risk of pressure sore development.

Regulatory Flags#

DUNS number
178180246
Device count
1
Premarket exempt
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B970FG2PRO0F-Scan GOF-Scan GO System with FootVIEW ProFG2PRO2024-03-14
B970FG20F-Scan GOF-Scan GO SystemFG22024-03-01
B970TD2000TekDAQ 200TekDAQ 200TD-2002024-03-01
B97030101250F-Scan GO 3010 Sensor3010-1252023-11-29
B9703000E12503000-E-125 F-Scan Sensor3000-E-125 F-Scan Sensor3000-E-1252020-11-03
B9703000E5003000-E-50 F-Scan Sensor3000-E-50 F-Scan Sensor3000-E-502020-11-03
B9703000ES03000-E-S F-Scan Sensor3000-E-S F-Scan Sensor3000-E-S2020-11-03
B9703000SPORTE12503000SPORT-E-125 F-Scan Sensor3000SPORT-E-125 F-Scan Sensor3000SPORT-E-1252020-11-03
B9703000SPORTE5003000SPORT-E-50 F-Scan Sensor3000SPORT-E-50 F-Scan Sensor3000SPORT-E-502020-11-03
B9703000SPORTES03000SPORT-E-S F-Scan Sensor3000SPORT-E-S F-Scan Sensor3000SPORT-E-S2020-11-03
B9703001E12503001-E-125 F-Scan Sensor3001-E-125 F-Scan Sensor3001-E-1252020-11-03
B9703001ES03001-E-S F-Scan Sensor3001-E-S F-Scan Sensor3001-E-S2020-11-03
B9703001SPORTE12503001SPORT-E-125 F-Scan Sensor3001SPORT-E-125 F-Scan Sensor3001SPORT-E-1252020-11-03
B9703001SPORTES03001SPORT-E-S F-Scan Sensor3001SPORT-E-S F-Scan Sensor3001SPORT-E-S2020-11-03
B9703005E12503005E- F-Scan XL Sport Left & Right Sensor (Sold as a pair only - price reflects3005E- F-Scan XL Sport Left & Right Sensor (Sold a3005E-1252020-11-03
B970302012503020-125 Sensor3020-125 Sensor3020-1252020-11-03
B97030221250Sensor, Matrix 3022-125Sensor, Matrix 3022-1253022-1252020-11-03
B970302412503024-125 Sensor3024-125 Sensor3024-1252020-11-03
B97030261250Sensor,Matrix,3026-125Sensor,Matrix,3026-1253026-1252020-11-03
B970302812503028-125 Senor3028-125 Sensor3028-1252020-11-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260242060217DIERS pedoscanDIERS International GmbHJFC2026-03-09
05425026002008Materialise Footscan Pro Level pressure plateMaterialise MotionJFC2026-01-31
05425026002015Materialise Footscan Pro Level pressure plateMaterialise MotionJFC2026-01-31
05425026002046Materialise Footscan Pro Level pressure plateMaterialise MotionJFC2026-01-31
05425026002053Materialise Footscan Pro Level pressure plateMaterialise MotionJFC2026-01-31
05391550080006Danu DANU SPORTS LIMITEDJFC2025-12-17
06941691920540Orantech Orantech Inc.JFC2024-12-17
06941691921134Orantech Orantech Inc.JFC2024-12-17
06941691909620Orantech Orantech Inc.JFC2024-12-05
06941691909736Orantech Orantech Inc.JFC2024-12-05
06941691910022Orantech Orantech Inc.JFC2024-12-05
06941691910619Orantech Orantech Inc.JFC2024-12-05
06941691910688Orantech Orantech Inc.JFC2024-12-05
06941691911425Orantech Orantech Inc.JFC2024-12-05
06941691982289Orantech Orantech Inc.JFC2024-12-05
06941691982296Orantech Orantech Inc.JFC2024-12-05
06941691982302Orantech Orantech Inc.JFC2024-12-05
03760349820055FeetMe Monitor FTM-DKFEETMEJFC2023-03-24
07540150603308BodiTrakVista Medical LtdJFC2022-12-13
07540150603780BodiTrakVista Medical LtdJFC2022-12-13
03760349820048FeetMe Monitor FTM-DKFEETMEJFC2022-11-11
B970303012503030-125 SensorTekscan, Inc.JFC2020-11-04
B9703000E12503000-E-125 F-Scan SensorTekscan, Inc.JFC2020-11-03
B9703000E5003000-E-50 F-Scan SensorTekscan, Inc.JFC2020-11-03
B9703000ES03000-E-S F-Scan SensorTekscan, Inc.JFC2020-11-03
B9703000SPORTE12503000SPORT-E-125 F-Scan SensorTekscan, Inc.JFC2020-11-03
B9703000SPORTE5003000SPORT-E-50 F-Scan SensorTekscan, Inc.JFC2020-11-03
B9703000SPORTES03000SPORT-E-S F-Scan SensorTekscan, Inc.JFC2020-11-03
B9703001E12503001-E-125 F-Scan SensorTekscan, Inc.JFC2020-11-03
B9703001ES03001-E-S F-Scan SensorTekscan, Inc.JFC2020-11-03