Digital Therapist

Basic Information

• Brand Name: Digital Therapist
• Primary DI: 05600775530136
• Version / Model: SWORDPhoenix-13
• Company Name: SWORD HEALTH, S.A.
• Labeler DUNS: 338007105
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-10-15
• Public Version: 3
• Public Version Date: 2024-02-16
• Public Version Status: Update
• Public Device Record Key: 969b82be-bfa4-4b68-a353-d94724484ec5

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: 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
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	05600775530136	GS1