ReJoyce

Basic Information

• Brand Name: ReJoyce
• Primary DI: 17540176010033
• 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: 2019-07-02
• Public Version: 4
• Public Version Date: 2024-02-16
• Public Version Status: Update
• Public Device Record Key: 3ae7a632-042a-4315-81f9-12ecf7ecd3b5

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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
ION	Exerciser, Non-Measuring	Physical Medicine	890.5370	1

GMDN Terms

Code	Name	Definition	Implantable	Status
48147	Virtual-display rehabilitation system, passive-support	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. It consists of a non-powered weight support (e.g., suspension sling, armrest) whereby the patient’s movements are detected by and presented on a dedicated computer/monitor with software.	No	Active
60926	Virtual-display rehabilitation system, non-supportive, home-use	An assembly of devices intended to be used both in a home and clinical setting and to provide non-gravity-compensating rehabilitation therapy for neuromuscular/musculoskeletal conditions affecting the back, trunk, and/or limbs (e.g., impaired limb function) through patient interaction with a videogame-like display prompting repeated motion of a body part (e.g., arm, hand, leg) for functional improvement; it may also provide performance feedback. It does not provide weight support and is based on motion-sensing devices [e.g., patient-worn infrared (IR) glove, motion tracking heel pad or camera, software] that communicate to provide a virtual-display interface.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	17540176010033	GS1