FDA.report

Empower

Primary DI
04064409013142
Brand
Empower
Company
OTTO BOCK HEALTHCARE
Model
1A1-1=R27-5/1-4
Device description
1A1-1 Empower, R, grey, beige
Published
2020-04-29
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

Product Codes

CodeName
ISWAssembly, Knee/Shank/Ankle/Foot, External

Product Code Classifications

CodeDeviceSpecialtyClass
ISWAssembly, Knee/Shank/Ankle/Foot, ExternalPhysical Medicine2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04032767840472PreviousGS10
04064409013142PrimaryGS10

GMDN Terms

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

Regulatory Flags

DUNS number
932133408
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
false
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
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
04064409000081MyCRO Band24H1=72021-03-29
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
04064409002719Empower1A1-2=L26-3/152021-03-01

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00860010894842Bio Leg™BIONICM INC.ISW2025-08-21
00860010894859Bio Leg™BIONICM INC.ISW2025-08-21
00860010894804Bio Leg™BIONICM INC.ISW2024-05-24
00860010894811Bio Leg™BIONICM INC.ISW2024-05-24
05690967648749Power KneeOSSUR AMERICAS, INC.ISW2022-07-08
05690967642822Power KneeOSSUR AMERICAS, INC.ISW2021-03-12
05690967642839Power KneeOSSUR AMERICAS, INC.ISW2021-03-12
05690967648381Power KneeOSSUR AMERICAS, INC.ISW2021-03-12
05690967648404Power KneeOSSUR AMERICAS, INC.ISW2021-03-12
04064409002634EmpowerOTTO BOCK HEALTHCAREISW2021-03-01
04064409002641EmpowerOTTO BOCK HEALTHCAREISW2021-03-01
04064409002658EmpowerOTTO BOCK HEALTHCAREISW2021-03-01
04064409002665EmpowerOTTO BOCK HEALTHCAREISW2021-03-01
04064409002672EmpowerOTTO BOCK HEALTHCAREISW2021-03-01
04064409002689EmpowerOTTO BOCK HEALTHCAREISW2021-03-01
04064409002696EmpowerOTTO BOCK HEALTHCAREISW2021-03-01
04064409002702EmpowerOTTO BOCK HEALTHCAREISW2021-03-01
04064409002719EmpowerOTTO BOCK HEALTHCAREISW2021-03-01
04064409002726EmpowerOTTO BOCK HEALTHCAREISW2021-03-01
04064409002733EmpowerOTTO BOCK HEALTHCAREISW2021-03-01
04064409002740EmpowerOTTO BOCK HEALTHCAREISW2021-03-01
04064409002757EmpowerOTTO BOCK HEALTHCAREISW2021-03-01
04064409002764EmpowerOTTO BOCK HEALTHCAREISW2021-03-01
04064409002771EmpowerOTTO BOCK HEALTHCAREISW2021-03-01
04064409002788EmpowerOTTO BOCK HEALTHCAREISW2021-03-01
04064409002795EmpowerOTTO BOCK HEALTHCAREISW2021-03-01
04064409002801EmpowerOTTO BOCK HEALTHCAREISW2021-03-01
04064409002818EmpowerOTTO BOCK HEALTHCAREISW2021-03-01
04064409002825EmpowerOTTO BOCK HEALTHCAREISW2021-03-01
04064409002832EmpowerOTTO BOCK HEALTHCAREISW2021-03-01