FDA.reportPublic FDA data

BodiTrak

Primary DI
07540150603308
Brand
BodiTrak
Company
Vista Medical Ltd
Model
BT2-2764-110
Device description
Hi-Res Torso
Published
2022-12-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
07540150603308PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540150603308075401506033087540150603308

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.

Contacts#

Phone, Email table
PhoneEmail
204-949-7674dkresovic@vista-medical.com

Regulatory Flags#

DUNS number
254518673
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540150603780BodiTrakBT2-0919-5142022-12-13
07540150602288BodiTrakBT15102022-01-13
07540150602318BodiTrakBT35102022-01-13
07540150602349BodiTrakBT50102022-01-13
07540150602370BodiTrakBT5010-10BB-0916B00002022-01-13
07540150602400BodiTrakBT5010-10BB-1016A00002022-01-13
07540150602431BodiTrakBT5010-10BB-1216A00002022-01-13
07540150602462BodiTrakBT5010-10BB-1616B00002022-01-13
07540150602493BodiTrakBT5010-60BB-1916A00002022-01-13
07540150602523BodiTrakBT5010-60BB-1916B00002022-01-13
07540150602554BodiTrakBT5010-60BB-2316A00002022-01-13
07540150602585BodiTrakBT5010-60BB-2416A00002022-01-13
07540150602615BodiTrakBT5010-30BB-2416B00002022-01-13
07540150602646BodiTrakBT5010-30BB-3516A00002022-01-13
07540150602677BodiTrakBT5010-30BB-3716A00002022-01-13
07540150602707BodiTrakBT5010-30BB-3916A00002022-01-13
07540150602738BodiTrakBT5010-30BB-4116B00002022-01-13
07540150602769BodiTrakBT5010-30BB-7216A00002022-01-13
07540150602974BodiTrakBT15122022-01-13
07540150603001BodiTrakBT15262022-01-13

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