FDA.reportPublic FDA data

VU

Primary DI
00860009142916
Brand
VU
Company
Wellsense, Inc.
Model
WS-MAT-200-04
Device description
The VU System provides real-time images of the contact pressure profile under a patient in a bed-care setting. The image gives caregivers a visual reference of where pressure is concentrated as they reposition patients according to their facility's care protocols. This product version is designed for use on bariatric beds / patients.
Published
2022-11-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00860009142916PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009142916008600091429168600091429160860009142916

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
080403189
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860009142923VUWS-MAT-200-062024-04-09
00860009142909VUWS-MAT-200-022022-11-29

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
00860009142923VUWellsense, Inc.JFC2024-04-09
03760349820055FeetMe Monitor FTM-DKFEETMEJFC2023-03-24
07540150603308BodiTrakVista Medical LtdJFC2022-12-13
07540150603780BodiTrakVista Medical LtdJFC2022-12-13
00860009142909VUWellsense, Inc.JFC2022-11-29
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