FDA.reportPublic FDA data

BiOM T2

Primary DI
B15520012190
Brand
BiOM T2
Company
BIONX MEDICAL TECHNOLOGIES, INC.
Model
2001219
Device description
BiOM T2 Wireless Tuning Device
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
ISWAssembly, Knee/Shank/Ankle/Foot, External

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISWAssembly, Knee/Shank/Ankle/Foot, ExternalPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B15520012190PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Laptop/tablet computerA small, non-dedicated computer designed to be portable. It includes a microprocessor [central processing unit (CPU)], a display screen, and a keyboard integrated into one unit. It includes batteries for mobile use, and uses mains electricity (AC-power) for charging the batteries and for desktop use. When used with dedicated software the computer may function as a medical device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
788290471
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B15520015960BiOM T220015962016-09-23
B155EM20emPOWERem22016-10-27
B155EM40emPOWERem42016-10-27
B15520017930BiOM T220017932016-09-23
B155EM30emPOWERem32016-10-27
B1551100A0BiOM T211-00A2016-09-23
B1551100ABLK0BiOM T211-00A-BLK2016-09-23
B1551100ASLV0BiOM T211-00A-SLV2016-09-23
B1551103A0BiOM T211-03A2016-09-23
B1551103B0BiOM T211-03B2016-09-23
B1551103S0BiOM T211-03S2016-09-23
B155EM0B0emPOWERem0B2016-10-27
B155EM0G0emPOWERem0G2016-10-27
B155EM1B0emPOWERem1B2016-10-27
B155EM1G0emPOWERem1G2016-10-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850004761106WalkasinsRxFunction, Inc.ISW2026-06-24
00850004761113WalkasinsRxFunction, Inc.ISW2026-06-24
00850004761120WalkasinsRxFunction, Inc.ISW2026-06-24
00850004761137WalkasinsRxFunction, Inc.ISW2026-06-24
00850004761144WalkasinsRxFunction, Inc.ISW2026-06-24
00850004761151WalkasinsRxFunction, Inc.ISW2026-06-24
00850004761168WalkasinsRxFunction, Inc.ISW2026-06-24
00850004761175WalkasinsRxFunction, Inc.ISW2026-06-24
04032767811571BiOM T2OTTO BOCK HEALTHCAREISW2018-04-11
04032767811588BiOM T2OTTO BOCK HEALTHCAREISW2018-04-11
04032767832842EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767832866EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767838882EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767838899EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767838905EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767838912EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767838929EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767838936EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767838943EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767838950EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767838967EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767838974EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767838981EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767838998EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767839001EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767839018EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767839025EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767839032EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767839049EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767839056EmpowerOTTO BOCK HEALTHCAREISW2018-04-11