PortableConnect

Basic Information

• Brand Name: PortableConnect
• Primary DI: 00860002828749
• Version / Model: 10100
• Catalog Number: 10100
• Company Name: Rom Technologies, Inc.
• Labeler DUNS: 117467897
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-03-20
• Public Version: 1
• Public Version Date: 2024-03-28
• Public Version Status: New
• Public Device Record Key: 62b843e8-8028-4172-9c90-51332eb51d09

Device Description

The PortableConnect System is a multi-purpose rehabilitation telemedicine system with physiological & musculoskeletal monitoring functionality.

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
67111	Multi-purpose rehabilitation telemedicine system	An electrically-powered assembly of devices intended for musculoskeletal and/or cardiac rehabilitation under remote consultation. It consists of a remotely adjustable static cycle-like therapy device with physiological monitoring functionality (e.g., pulse oximetery, blood pressure, ECG), joint mobility sensors, and a display/video monitor for telemedicine functionality. It can be used in the home and/or healthcare facility.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860002828749	GS1

Customer Contacts

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