FDA.reportPublic FDA data

BPMS Evolution

Primary DI
B970BCE531510
Brand
BPMS Evolution
Company
Tekscan, Inc.
Model
BPMS 1 System (5315 Sensors)
Catalog number
BCE5315-1
Device description
Includes 1 Evolution Handle, BPMS Clinical Software CD with Sensor Map corresponding to Sensor 5315, Help File and PDF of System Manual, System Carrying Case, Sensor Carrying Case, (2) 5315 Sensors with Sensor Cover, and 1 Web-Based Training Session (USA Only)
Published
2020-10-14
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
B970BCE531510PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Pressure measurement/mapping system, anatomicalA mains electricity (AC-powered) assembly of electronic devices intended to be used to measure the actual pressure between an anatomical body surface and supporting media. Typically using an array of pressure sensors this system will provide a map of applied pressure between, e.g., a seating cushion and the anatomical shape of the patient. This system is typically used to customize the shape of seating cushions to reduce the risk of pressure sores developing from long-term use of the cushion, such as in wheelchair seating customization.

Sterilization Methods#

Method table
Method

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
07649998859011NUSHUMagnes AGJFC2026-05-31
07649998859028NUSHUMagnes AGJFC2026-05-31
07649998859035NUSHUMagnes AGJFC2026-05-31
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
03760349820055FeetMe Monitor FTM-DKFEETMEJFC2023-03-24
07540150603308BodiTrakVista Medical LtdJFC2022-12-13
07540150603780BodiTrakVista Medical LtdJFC2022-12-13
03760349820048FeetMe Monitor FTM-DKFEETMEJFC2022-11-11
00842430109027Avra Smart Hub Powered by BodiTrakMIZUHO ORTHOPEDIC SYSTEMS, INC.JFC2021-06-14
00842430110283AVRA HEAD SECTION 3IN STERIS 3080, 3085MIZUHO ORTHOPEDIC SYSTEMS, INC.JFC2021-06-14
00842430110290AVRA BACK SECTION 3IN STERIS 3080, 3085MIZUHO ORTHOPEDIC SYSTEMS, INC.JFC2021-06-14
00842430110306AVRA FOOT SECTION, 3IN, STERIS 3080, 3085MIZUHO ORTHOPEDIC SYSTEMS, INC.JFC2021-06-14
00842430110641AVRA 3-PC SET 3IN STERIS 3080 3085MIZUHO ORTHOPEDIC SYSTEMS, INC.JFC2021-06-14
00842430111266AVRA WIRELESS TABLET DISPLAYMIZUHO ORTHOPEDIC SYSTEMS, INC.JFC2021-06-14
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
B9703001SPORTE12503001SPORT-E-125 F-Scan SensorTekscan, Inc.JFC2020-11-03