FDA.reportPublic FDA data

Empower

Primary DI
04032767832866
Brand
Empower
Company
OTTO BOCK HEALTHCARE
Model
560X11=V2
Device description
Tuning Device
Published
2018-04-11
Public version status
Update
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
B155EM40PreviousHIBCC0
04032767832866PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04032767832866040327678328664032767832866

GMDN Terms#

Term, Definition table
TermDefinition
Portable computerA portable, non-dedicated, and commonly hand-held computing device intended for the download/running of medical software to input, process and/or display data. It typically includes a microprocessor [central processing unit (CPU)], a display screen, and a keyboard and/or touchscreen integrated into one unit in the form of a laptop, tablet, palmtop or other hand-held (including smartphone) device.

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
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
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