Medium Tricycle

Basic Information

• Brand Name: Medium Tricycle
• Primary DI: 00858101008537
• Version / Model: R130
• Company Name: RIFTON EQUIPMENT
• Labeler DUNS: 808251438
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-13
• Public Version: 2
• Public Version Date: 2023-05-08
• Public Version Status: Update
• Public Device Record Key: 9573dd4f-2dbf-4088-8208-6641b335f42e
• Distribution End Date: 2023-05-08

Device Description

Adaptive Tricycle

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: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
ION	Exerciser, Non-Measuring	Physical Medicine	890.5370	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31142	Assistive foot-propelled tricycle	A vehicle with three wheels mounted on a slender frame which the user with a disability sits astride and pedals with their legs to provide a means of transportation, typically without the attendance of another person. It is designed to be operated by the user. The vehicle will enhance the user's independence in short- to medium-range transportation.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00858101008537	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]