AccessGUDID - DEVICE: REOGO (07290017844114)

GUDID

Device Identifier (DI) Information

Brand Name: REOGO
Version or Model: 09
Commercial Distribution Status: In Commercial Distribution
Catalog Number: REOGO005SYS
Company Name: MOTORIKA MEDICAL (ISRAEL) LTD

Primary DI Number: 07290017844114
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 534078621 *Terms of Use

Device Description: The ReoGoTM therapy platform is a computerized robotics-based system for retraining patients with motor limitations, recovering from CVA or other neuromuscular conditions. The Motorika ReoGo™ System is rehabilitative exercise device intended for medical purposes, such as to measure, evaluate, and increase the strength of muscles and the range of motion of joints specifically designed to prevent the adhesion and contracture of joints, to improve the patients’ range of motion and functional capabilities of the upper extremity.

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?
47517	Virtual-display rehabilitation system, powered-support, upper-limb	An assembly of devices intended to be used in a clinical setting to provide gravity-compensating rehabilitation therapy for neuromuscular/musculoskeletal conditions affecting the upper limbs (e.g., impaired arm function) through patient interaction with a videogame-like display prompting repeated motion of the limb under treatment (e.g., arm, hand, wrist, shoulder) for functional improvement (e.g., reaching, grasping); it may also provide performance feedback and manual/automatic setting adjustments. It consists of a limb support capable of actively assisting the patient’s movements (e.g., powered robotic arm), and a computer/monitor with software.	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: dbca90c1-356e-434c-8cfe-c095a9143f36
Public Version Date: August 05, 2022
Public Version Number: 2
DI Record Publish Date: November 30, 2019