FDA.reportPublic FDA data

emPOWER

Primary DI
B155EM0B0
Brand
emPOWER
Company
BIONX MEDICAL TECHNOLOGIES, INC.
Model
em0B
Device description
emPOWER Ankle System, Black
Published
2016-10-27
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
B155EM0B0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dynamic-response foot prosthesisAn artificial substitute for a foot designed as a component of an external lower-limb prosthesis to restore some of the appearance and/or function of the normal anatomy. It is available in a variety of designs (e.g., it may resemble the form of a natural foot, or have a split-toe design) and its construction is intended to enable the store and release of energy during the walking cycle to provide a sense of push-off and a more normal gait range. A dynamic-response foot is typically intended for an active and responsive patient to help increase activity level (e.g., vary walking speed, change direction quickly, walk long distances).

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
B15520012190BiOM T220012192016-09-23
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
B155EM0G0emPOWERem0G2016-10-27
B155EM1B0emPOWERem1B2016-10-27
B155EM1G0emPOWERem1G2016-10-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
04032767839063EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767839070EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767839087EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767839094EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767839100EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767839117EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767839124EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767839131EmpowerOTTO BOCK HEALTHCAREISW2018-04-11