AccessGUDID - DEVICE: ReJoyce (17540176010002)

GUDID

Device Identifier (DI) Information

Brand Name: ReJoyce
Version or Model: RV10
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Rehabtronics Inc

Primary DI Number: 17540176010002
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 243936569 *Terms of Use

Device Description: The ReJoyce is a rehabilitation device intended to increase the strength of muscles and the range of motion of joints of the upper extremities. The ReJoyce helps patients to retrain and condition their muscles by using their hands and arms to play interactive computer games. The activities required by the computer games are similar to tasks used in everyday life, such as pouring a drink or opening a jar. Practicing these motions will help patients to replicate them in real life.

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):	No
Over the Counter (OTC):	Yes
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?
58060	Virtual-display arm rehabilitation system, non-gravity-compensating	An assembly of devices designed to provide non-gravity-compensating therapy for a patient who has lost motor function of the arm(s), caused by cerebral, neurogenic, spinal, muscular or bone-related disorders, through interaction with a software program prompting repeated motion of the arms, fingers, and hands to improve reaching/grasping mobility. It consists of an infrared (IR) tracking camera, patient data gloves with integrated IR-emitting sensors, visual display unit (VDU), and computer-calculated arm/finger position and training software. It is used for inpatients, outpatients or home settings for patients able to understand and interact with the audio-visual instructions.	Obsolete	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
Storage Environment Temperature: between -18 and 60 Degrees Celsius
Storage Environment Humidity: between 15 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f94e5883-392d-4b16-ab20-0ee44637fe7a
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 23, 2016