Empower

GUDID 04064409013425

1A1-1 Empower, R, grey, beige

OTTO BOCK HEALTHCARE

Mechatronic external ankle-foot prosthesis

• Primary Device ID: 04064409013425
• NIH Device Record Key: 2664d823-5307-43ab-9243-9d8a7fcfc20e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Empower
• Version Model Number: 1A1-1=R28-8/1-4
• Company DUNS: 932133408
• Company Name: OTTO BOCK HEALTHCARE
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04032767840755 [Previous]
GS1	04064409013425 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-07
• Device Publish Date: 2020-04-29

On-Brand Devices [Empower]

• B155EM30: Empower Charger
• 04064409255931: 1A1-1 Empower
• 04064409013777: 1A1-1 empower (Service/Test)
• 04064409013760: 1A1-1 Empower, R, black, beige
• 04064409013753: 1A1-1 Empower, R, black, brown
• 04064409013746: 1A1-1 Empower, R, grey, beige
• 04064409013739: 1A1-1 Empower, R, grey, brown
• 04064409013722: 1A1-1 Empower, R, black, beige
• 04064409013715: 1A1-1 Empower, R, black, brown
• 04064409013708: 1A1-1 Empower, R, grey, beige
• 04064409013692: 1A1-1 Empower, R, grey, brown
• 04064409013685: 1A1-1 Empower, R, black, beige
• 04064409013678: 1A1-1 Empower, R, black, brown
• 04064409013661: 1A1-1 Empower, R, grey, beige
• 04064409013654: 1A1-1 Empower, R, grey, brown
• 04064409013647: 1A1-1 Empower, R, black, beige
• 04064409013630: 1A1-1 Empower, R, black, brown
• 04064409013623: 1A1-1 Empower, R, grey, beige
• 04064409013616: 1A1-1 Empower, R, grey, brown
• 04064409013609: 1A1-1 Empower, R, black, beige
• 04064409013593: 1A1-1 Empower, R, black, brown
• 04064409013586: 1A1-1=R29-8/1-4
• 04064409013579: 1A1-1 Empower, R, grey, brown
• 04064409013562: 1A1-1 Empower, R, black, beige
• 04064409013555: 1A1-1 Empower, R, black, brown
• 04064409013548: 1A1-1 Empower, R, grey, beige
• 04064409013531: 1A1-1 Empower, R, grey, brown
• 04064409013524: 1A1-1 Empower, R, black, beige
• 04064409013517: 1A1-1 Empower, R, black, brown
• 04064409013500: 1A1-1 Empower, R, grey, beige
• 04064409013494: 1A1-1 Empower, R, grey, brown
• 04064409013487: 1A1-1 Empower, R, black, beige
• 04064409013470: 1A1-1 Empower, R, black, brown
• 04064409013463: 1A1-1 Empower, R, grey, beige
• 04064409013456: 1A1-1 Empower, R, grey, brown
• 04064409013449: 1A1-1 Empower, R, black, beige
• 04064409013432: 1A1-1 Empower, R, black, brown
• 04064409013425: 1A1-1 Empower, R, grey, beige
• 04064409013418: 1A1-1 Empower, R, grey, brown
• 04064409013401: 1A1-1 Empower, R, black, beige
• 04064409013395: 1A1-1 Empower, R, black, brown
• 04064409013388: 1A1-1 Empower, R, grey, beige
• 04064409013371: 1A1-1 Empower, R, grey, brown
• 04064409013364: 1A1-1 Empower, R, black, beige
• 04064409013357: 1A1-1 Empower, R, black, brown
• 04064409013340: 1A1-1 Empower, R, grey, beige
• 04064409013333: 1A1-1 Empower, R, grey, brown
• 04064409013326: 1A1-1 Empower, R, black, beige
• 04064409013319: 1A1-1 Empower, R, black, brown
• 04064409013302: 1A1-1 Empower, R, grey, beige