scalamobil®

Basic Information

• Brand Name: scalamobil®
• Primary DI: 04046727172114
• Version / Model: S35
• Company Name: Alber GmbH
• Labeler DUNS: 340348858
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-04-27
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: f610ee21-bab1-4faa-94ee-2971f52b80a8

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
ING	Elevator, Wheelchair, Portable	Physical Medicine	890.3930	2

GMDN Terms

Code	Name	Definition	Implantable	Status
30039	Stairclimber	A non-fixed mechanical device designed to transport a disabled or infirm person up or down stairs and can be controlled by an attendant/nursing staff, or the user.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04046727172114	GS1

Premarket Submissions

Submission Number	Supplement Number
K920105	000