ReJoyce

Basic Information

• Brand Name: ReJoyce
• Primary DI: 17540176010002
• Version / Model: RV10
• Company Name: Rehabtronics Inc
• Labeler DUNS: 243936569
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-23
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: f94e5883-392d-4b16-ab20-0ee44637fe7a

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

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IKK	System, Isokinetic Testing And Evaluation	Physical Medicine	890.1925	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	17540176010002	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -18 – 60 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 15 – 90 Percent (%) Relative Humidity