Lokomat

Basic Information

• Brand Name: Lokomat
• Primary DI: 07640174660247
• Version / Model: Pro
• Catalog Number: 32000
• Company Name: HOCOMA AG
• Labeler DUNS: 487876203
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-22
• Public Version: 3
• Public Version Date: 2020-05-06
• Public Version Status: Update
• Public Device Record Key: 527bc5d8-c1a6-425a-a4f4-72e1eb264894

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• 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: Yes
• 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
IKK	System, Isokinetic Testing And Evaluation	Physical Medicine	890.1925	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47516	Treadmill/elliptical gait rehabilitation system	An assembly of electrically-powered devices designed to assist a patient with a walking disability (neurogenic, muscular, or osseous in origin) regain lost motor function. It primarily consists of a speed-regulated treadmill or elliptical to facilitate gait; an overhead patient support assembly with pulleys, harness, and straps to unload patient weight; a robotic orthosis system attached to the patient's legs individually, or in the form of pedals, to guide leg movements; side-mounted rails for patient support; an operator control unit to regulate speed/elevation and display related data; and sometimes patient incentive features.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07640174660247	GS1