PortableConnect

Basic Information

• Brand Name: PortableConnect
• Primary DI: 00860002828718
• Version / Model: 10100
• Catalog Number: 10100
• Company Name: Rom Technologies, Inc
• Labeler DUNS: 117410715
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-10-02
• Public Version: 2
• Public Version Date: 2021-08-09
• Public Version Status: Update
• Public Device Record Key: 44620674-07fd-41dd-9032-ce7ecd18ea18

Device Description

The PortableConnect System is a rehabilitative exercise therapy device to increase range of motion

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
10385	Bicycle exerciser	An exercise apparatus designed to provide the same physical activity of pedalling a bicycle while remaining stationary, primarily to increase cardiovascular endurance by keeping the heart and respiration rates elevated over a continuous period; it may also promote lower-body, stomach, arm, and back muscle strength. The device typically consists of a bicycle-like frame mounted on struts, pedals geared via a chain or belt to a variable resistance, handlebars, with a fixed seat or attachment for a wheelchair. It may include workout program modes to adjust the resistance level, a monitor to display the workout time, distance, speed, calories burned, and heart rate.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860002828718	GS1

Customer Contacts

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