AccessGUDID - DEVICE: InTandem (00860001790801)

GUDID

Device Identifier (DI) Information

Brand Name: InTandem
Version or Model: 0010
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Medrhythms, Inc.

Primary DI Number: 00860001790801
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080565076 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HCC	Device, Biofeedback

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c1ddeaf1-2774-446a-9549-1fb00d35ba78
Public Version Date: March 10, 2025
Public Version Number: 2
DI Record Publish Date: October 27, 2023