parawalk 3m

Basic Information

• Brand Name: parawalk 3m
• Primary DI: 04050588002022
• Version / Model: cos30018va02
• Catalog Number: cos30018va02
• Company Name: h/p/cosmos sports & medical gmbh
• Labeler DUNS: 341362614
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-01-07
• Public Version: 1
• Public Version Date: 2020-01-15
• Public Version Status: New
• Public Device Record Key: cb301335-81f7-4a79-aaad-e2153bfbdc97

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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
IOE	Bars, Parallel, Exercise	Physical Medicine	890.5370	1

GMDN Terms

Code	Name	Definition	Implantable	Status
30926	Parallel bar exerciser, non-powered	An exercise apparatus designed to assist users in maintaining good walking posture, particularly a person with a disability, a paraplegic, or a patient who has suffered a stroke and is learning to walk. It typically consists of two parallel wooden or steel handrails each one supported by two poles and base plates; the user holds the bars, which may be manually height and width-adjustable, thus relieving his/her weight when walking. The device is intended to improve the user?s balance as well as coordination and flexibility; additionally, it can improve the muscle strength in the lower limbs.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04050588002022	GS1