PortableConnect 10100

GUDID 00860002828749

Multi-purpose rehabilitation telemedicine system

Primary Device ID	00860002828749
NIH Device Record Key	62b843e8-8028-4172-9c90-51332eb51d09
Commercial Distribution Status	In Commercial Distribution
Brand Name	PortableConnect
Version Model Number	10100
Catalog Number	10100
Company DUNS	117467897
Company Name	Rom Technologies, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00860002828749 [Primary]

IKK	System, Isokinetic Testing And Evaluation

Steralize Prior To Use	false
Device Is Sterile	false

Mark Image Registration \| Serial	Company Trademark Application Date
PORTABLECONNECT 88221843 not registered Live/Pending	ROM3 Rehab LLC 2018-12-07
PORTABLECONNECT 88216944 not registered Live/Pending	ROM3 Rehab LLC 2018-12-04