AccessGUDID - DEVICE: PortableConnect (00860002828749)

GUDID

Device Identifier (DI) Information

Brand Name: PortableConnect
Version or Model: 10100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10100
Company Name: Rom Technologies, Inc.

Primary DI Number: 00860002828749
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117467897 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IKK	System, Isokinetic Testing And Evaluation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 62b843e8-8028-4172-9c90-51332eb51d09
Public Version Date: March 28, 2024
Public Version Number: 1
DI Record Publish Date: March 20, 2024