InTandem

GUDID 00860001790801

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.

Medrhythms, Inc.

Neuromuscular rehabilitation software

• Primary Device ID: 00860001790801
• NIH Device Record Key: c1ddeaf1-2774-446a-9549-1fb00d35ba78
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InTandem
• Version Model Number: 0010
• Company DUNS: 080565076
• Company Name: Medrhythms, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860001790801 [Primary]

FDA Product Code

• HCC: Device, Biofeedback

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-06
• Device Publish Date: 2023-10-27

Devices Manufactured by Medrhythms, Inc.

• 00860001790818 - Movive: 2025-03-18 Movive is indicated to support gait rehabilitation and motor function for people living with Parkinson's disease. Movive is inte
• 00860001790801 - InTandem: 2023-11-06InTandem 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.
• 00860001790801 - InTandem: 2023-11-06 InTandem is indicated to improve walking and ambulation in adult chronic stroke patients. InTandem is intended to be used in the