FDA.reportPublic FDA data

3000-E-125 F-Scan Sensor

Primary DI
B9703000E1250
Brand
3000-E-125 F-Scan Sensor
Company
Tekscan, Inc.
Model
3000-E-125 F-Scan Sensor
Catalog number
3000-E-125
Device description
3000-E-125 F-Scan Sensor
Published
2020-11-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
B9703000E1250PrimaryHIBCC0

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
Lot or batch
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
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
B970303012503030-125 Sensor3030-125 Sensor3030-1252020-11-04

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
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
B9703001SPORTE12503001SPORT-E-125 F-Scan SensorTekscan, Inc.JFC2020-11-03