InTandem Education Unit

Basic Information

• Brand Name: InTandem Education Unit
• Primary DI: 00860001790825
• Version / Model: 001EDU
• Company Name: Medrhythms, Inc.
• Labeler DUNS: 080565076
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-06-13
• Public Version: 2
• Public Version Date: 2026-03-17
• Public Version Status: Update
• Public Device Record Key: 5d238454-6cd1-4399-b427-dd0ce57bbf5d

Device Description

Education Unit for InTandem

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
HCC	Device, Biofeedback	Neurology	882.5050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63475	Physical/neuromuscular rehabilitation software	A software program intended to help a patient regain functional physical and/or neuromuscular control through guided activities (e.g., physiotherapy exercises, visuomotor stimulating onscreen patterns, interactive games, speech exercises), in cases of musculoskeletal, neurological, and/or oral-motor conditions/events (e.g., trauma, Parkinson’s, stroke, traumatic brain injury). It is intended to be used in the home on a non-medical device (e.g., tablet, smartphone, computer); it is not intended to interface with external biomechanical function analysis equipment. Some types involve clinical supervision or consultation.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860001790825	GS1