REAL y-Series

Basic Information

• Brand Name: REAL y-Series
• Primary DI: 00815948029484
• Version / Model: RLYGO1-A
• Company Name: PENUMBRA, INC.
• Labeler DUNS: 191077671
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-04-16
• Public Version: 1
• Public Version Date: 2024-04-24
• Public Version Status: New
• Public Device Record Key: d6bdc5c7-4420-4f4e-8acf-9d6aa7bf32d2

Device Description

REAL y-Series GO

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
ISD	Exerciser, Measuring	Physical Medicine	890.5360	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60925	Virtual-display rehabilitation system, non-supportive, clinical	An assembly of devices intended to be used in a clinical setting to provide non-gravity-compensating rehabilitation therapy for neuromuscular/musculoskeletal conditions affecting the back/trunk/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., battery-powered patient-worn infrared (IR) glove, motion tracking heel pad, movement tracking camera, software] that communicate wirelessly to provide a virtual-display interface.	No	Active
65392	Mental health/function therapeutic software, virtual reality	A virtual reality software program intended to be used with an off-the-shelf device in conjunction with a virtual reality headset (not included) to help improve mental health/wellbeing (e.g., control effects of mood disorders, stress) and/or a cognitive function (e.g., attention/concentration, reading ability) by providing a patient with an interactive, immersive game; it is not intended for kinesiology-based neuromuscular rehabilitation. It is intended to be used by the patient at home, school, and in clinical settings in conjunction with clinician consultation.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00815948029484	GS1

Premarket Submissions

Submission Number	Supplement Number
K183296	000