e-fix®

GUDID 04046727217006

Alber GmbH

Wheelchair electric-motor-driven propulsion system Wheelchair electric-motor-driven propulsion system Wheelchair electric-motor-driven propulsion system Wheelchair electric-motor-driven propulsion system Wheelchair electric-motor-driven propulsion system Wheelchair electric-motor-driven propulsion system Wheelchair electric-motor-driven propulsion system Wheelchair electric-motor-driven propulsion system Wheelchair electric-motor-driven propulsion system Wheelchair electric-motor-driven propulsion system Wheelchair electric-motor-driven propulsion system Wheelchair electric-motor-driven propulsion system Wheelchair electric-motor-driven propulsion system Wheelchair electric-motor-driven propulsion system Wheelchair electric-motor-driven propulsion system Wheelchair electric-motor-driven propulsion system Wheelchair electric-motor-driven propulsion system

• Primary Device ID: 04046727217006
• NIH Device Record Key: ff5c81d6-6440-429f-943c-3ffa924cce7f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: e-fix®
• Version Model Number: E35 eco
• Company DUNS: 340348858
• Company Name: Alber GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	04046727217006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161241

FDA Product Code

• ITI: Wheelchair, Powered

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: 2021-12-24
• Device Publish Date: 2021-12-16

On-Brand Devices [e-fix®]

• 04046727217266: E35 eco
• 04046727217006: E35 eco
• 04046727216993: E35 eco
• 04046727216986: E35 eco
• 04046727216979: E35 eco
• 04046727216962: E35 eco
• 04046727216955: E35 eco
• 04046727216948: E35 eco
• 04046727216931: E35 eco
• 04046727216924: E35 eco
• 04046727216917: E35 eco
• 04046727216900: E35 eco
• 04046727216894: E35 eco