Empower

Basic Information

• Brand Name: Empower
• Primary DI: 04064409003549
• Version / Model: 1A1-2=R28-6/4
• Company Name: OTTO BOCK HEALTHCARE
• Labeler DUNS: 932133408
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-01
• Public Version: 1
• Public Version Date: 2021-03-09
• Public Version Status: New
• Public Device Record Key: 9dba1dc9-8dbc-4f19-b0c8-6e942a32dfd4

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ISW	Assembly, Knee/Shank/Ankle/Foot, External	Physical Medicine	890.3500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64725	Mechatronic external ankle-foot prosthesis	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04064409003549	GS1