FDA.report

BodiTrak

Primary DI
07540150600185
Brand
BodiTrak
Company
Vista Medical Ltd
Model
BT2-0816-604
Device description
in-shoe 29cm
Published
2021-08-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
JFCSystem, Pressure Measurement, Intermittent

Product Code Classifications

CodeDeviceSpecialtyClass
JFCSystem, Pressure Measurement, IntermittentPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07540150600185PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07540150600185075401506001857540150600185

GMDN Terms

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.

Sterilization Methods

Method

Contacts

PhoneEmail
204-949-7674jkippen@vista-medical.com

Regulatory Flags

DUNS number
254518673
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
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 DIBrandModelCatalogPublished
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
07540150603032BodiTrakBT15282022-01-13

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