InTandem

Basic Information

• Brand Name: InTandem
• Primary DI: 00860001790801
• Version / Model: 0010
• Company Name: Medrhythms, Inc.
• Labeler DUNS: 080565076
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-27
• Public Version: 1
• Public Version Date: 2023-11-06
• Public Version Status: New
• Public Device Record Key: c1ddeaf1-2774-446a-9549-1fb00d35ba78

Device Description

InTandem is indicated to improve walking and ambulation in adult chronic stroke patients. InTandem is intended to be used in the home for the physical rehabilitation of ambulatory adults with chronic stroke walking impairments.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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	Neuromuscular rehabilitation software	A software program intended to be used by a patient whose neuromuscular abilities have been impaired by a disease/condition (e.g., Parkinson’s, stroke, traumatic brain injury) to help train and regain neuromuscular control (e.g., balance, strength, speech) through guided activities (e.g., visuomotor stimulating onscreen patterns, tailored exercise regimes, interactive games). It is intended to be used on a non-medical computerized device (e.g., tablet, smartphone) for use in the home; it is not intended to interface with external biomechanical function analysis equipment.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860001790801	GS1