AccessGUDID - DEVICE: PortableConnect (00860002828718)

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: 00860002828718
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117410715 *Terms of Use

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

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?
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.	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: 44620674-07fd-41dd-9032-ce7ecd18ea18
Public Version Date: August 09, 2021
Public Version Number: 2
DI Record Publish Date: October 02, 2020