emPOWER

GUDID B155EM0B0

emPOWER Ankle System, Black

BIONX MEDICAL TECHNOLOGIES, INC.

Dynamic-response foot prosthesis

• Primary Device ID: B155EM0B0
• NIH Device Record Key: 71f1f28f-00c5-4845-b7d8-74f8d01a4eaf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: emPOWER
• Version Model Number: em0B
• Company DUNS: 788290471
• Company Name: BIONX MEDICAL TECHNOLOGIES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B155EM0B0 [Primary]

FDA Product Code

• ISW: Assembly, Knee/Shank/Ankle/Foot, External

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-10-27

On-Brand Devices [emPOWER]

• B155EM40: Wireless Tuning Device
• B155EM20: emPOWER Battery
• B155EM1G0: emPOWER, Ankle only, Gray
• B155EM1B0: emPOWER, Ankle only, Black
• B155EM0G0: emPOWER Ankle System, Gray
• B155EM0B0: emPOWER Ankle System, Black