FDA.reportPublic FDA data

Empower

Primary DI
04064409003402
Brand
Empower
Company
OTTO BOCK HEALTHCARE
Model
1A1-2=R27-4/4
Published
2021-03-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
04064409003402PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04064409003402040644090034024064409003402

GMDN Terms#

Term, Definition table
TermDefinition
Mechatronic external ankle-foot prosthesisA battery-powered electromechanical device which is a component of an external lower limb prosthesis designed to functionally replace, in part or total, an absent foot and/or ankle, wherein the principle of operation for dorsiflexion/plantar flexion motion control is based on hydraulic, pneumatic, or magnetorheological actuation regulated by a motion-feedback mechanism using electronic sensors and software. It is intended to respond to changes in motion in real-time by continuously sensing motion and temperature and instantly adjusting motion resistance within a single step. Also known as a microprocessor-controlled ankle-foot (MPF), it may have various designs and functional features.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
932133408
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04064409000081MyCRO Band24H1=72021-03-29
04032767811571BiOM T2757B162018-04-11
04032767832859Empower757B382018-04-11
04064409000012MyCRO Band24H1=12021-03-29
04064409000029MyCRO Band24H1=112021-03-29
04064409000036MyCRO Band24H1=122021-03-29
04064409000043MyCRO Band24H1=132021-03-29
04064409000050MyCRO Band24H1=2.52021-03-29
04064409000067MyCRO Band24H1=32021-03-29
04064409000074MyCRO Band24H1=52021-03-29
04064409000098MyCRO Band24H1=82021-03-29
04064409000104MyCRO Band24H1=92021-03-29
04064409002634Empower1A1-2=L25-3/152021-03-01
04064409002641Empower1A1-2=L25-3/42021-03-01
04064409002658Empower1A1-2=L25-4/152021-03-01
04064409002665Empower1A1-2=L25-4/42021-03-01
04064409002672Empower1A1-2=L25-5/152021-03-01
04064409002689Empower1A1-2=L25-5/42021-03-01
04064409002696Empower1A1-2=L25-6/152021-03-01
04064409002702Empower1A1-2=L25-6/42021-03-01

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