Empower

Basic Information

• Brand Name: Empower
• Primary DI: 04032767832866
• Version / Model: 560X11=V2
• Company Name: OTTO BOCK HEALTHCARE
• Labeler DUNS: 932133408
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-04-11
• Public Version: 2
• Public Version Date: 2020-08-20
• Public Version Status: Update
• Public Device Record Key: d8761ac8-d6bd-4b40-8510-a7ae5f087a4f

Device Description

Tuning Device

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
38453	Portable computer	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Previous	B155EM40	HIBCC
Primary	04032767832866	GS1