e-fix®

Basic Information

• Brand Name: e-fix®
• Primary DI: 04046727216948
• Version / Model: E35 eco
• Company Name: Alber GmbH
• Labeler DUNS: 340348858
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-12-16
• Public Version: 1
• Public Version Date: 2021-12-24
• Public Version Status: New
• Public Device Record Key: 8bbfaf0c-aea1-486b-9579-be1f0b5e5e04

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
ITI	Wheelchair, Powered	Physical Medicine	890.3860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42805	Wheelchair electric-motor-driven propulsion system	An assembly of devices added/retrofitted to a manual wheelchair (occupant or attendant driven) to provide the occupant with an electrical-powered drive mechanism, including the energy source (batteries) to achieve this. The steering, control, and brake systems will typically be included. This retrofitted accessory may alter the wheel configuration of the wheelchair in order to provide the powered propulsion (e.g., from a conventional four-wheeled to a tricycle configuration or additional propulsion wheels at the rear of the wheelchair).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04046727216948	GS1

Premarket Submissions

Submission Number	Supplement Number
K161241	000