MindPod Dolphin

GUDID 03760272650026

Dolphin 2.0 is an immersive virtual reality software to help motivate people and patients to train complex upper body exploratory movements for both cognitive and motor rehabilitation. Patient assessment, exercise guidance, and approval by the medical professional is required prior to use. The intended users of the Dolphin 2.0 are physiotherapists, occupational therapists, various caregivers and patients. The rehabilitation is targeted at adult patients who have brain injury, stroke or other neurological diseases and are in acute, sub-acute or chronic settings.

MindMaze SA

Virtual-display rehabilitation system, non-supportive, clinical

• Primary Device ID: 03760272650026
• NIH Device Record Key: a736e37b-ac3a-4a80-b4a2-6aa567e4c0fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MindPod Dolphin
• Version Model Number: DLP-01
• Company DUNS: 486449510
• Company Name: MindMaze SA
• 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: true
• Serial Number: false
• 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

Customer Support Contacts

• Phone: +41215520804
• Email: regulatory.affairs@mindmaze.ch
• Phone: +41215520804
• Email: regulatory.affairs@mindmaze.ch
• Phone: +41215520804
• Email: regulatory.affairs@mindmaze.ch
• Phone: +41215520804
• Email: regulatory.affairs@mindmaze.ch
• Phone: +41215520804
• Email: regulatory.affairs@mindmaze.ch
• Phone: +41215520804
• Email: regulatory.affairs@mindmaze.ch
• Phone: +41215520804
• Email: regulatory.affairs@mindmaze.ch
• Phone: +41215520804
• Email: regulatory.affairs@mindmaze.ch
• Phone: +41215520804
• Email: regulatory.affairs@mindmaze.ch
• Phone: +41215520804
• Email: regulatory.affairs@mindmaze.ch
• Phone: +41215520804
• Email: regulatory.affairs@mindmaze.ch
• Phone: +41215520804
• Email: regulatory.affairs@mindmaze.ch
• Phone: +41215520804
• Email: regulatory.affairs@mindmaze.ch
• Phone: +41215520804
• Email: regulatory.affairs@mindmaze.ch
• Phone: +41215520804
• Email: regulatory.affairs@mindmaze.ch
• Phone: +41215520804
• Email: regulatory.affairs@mindmaze.ch
• Phone: +41215520804
• Email: regulatory.affairs@mindmaze.ch
• Phone: +41215520804
• Email: regulatory.affairs@mindmaze.ch
• Phone: +41215520804
• Email: regulatory.affairs@mindmaze.ch
• Phone: +41215520804
• Email: regulatory.affairs@mindmaze.ch
• Phone: +41215520804
• Email: regulatory.affairs@mindmaze.ch
• Phone: +41215520804
• Email: regulatory.affairs@mindmaze.ch
• Phone: +41215520804
• Email: regulatory.affairs@mindmaze.ch
• Phone: +41215520804
• Email: regulatory.affairs@mindmaze.ch
• Phone: +41215520804
• Email: regulatory.affairs@mindmaze.ch
• Phone: +41215520804
• Email: regulatory.affairs@mindmaze.ch
• Phone: +41215520804
• Email: regulatory.affairs@mindmaze.ch
• Phone: +41215520804
• Email: regulatory.affairs@mindmaze.ch
• Phone: +41215520804
• Email: regulatory.affairs@mindmaze.ch

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760272650026 [Primary]

FDA Product Code

• ION: Exerciser, Non-Measuring

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: 2019-07-05
• Device Publish Date: 2019-06-27

Devices Manufactured by MindMaze SA

• 03760272650002 - MindMotion PRO: 2021-06-08 MindMotionPRO is a 3D imaging and display system that interactively displays and tracks upper-extremity rehabilitation exercises
• 03760272650019 - MindMotion™ GO: 2021-06-08 MindMotion™ GO is a medical device software used in combination with the Microsoft Kinect v2 and Leap Motion controller that s
• 03760272650026 - MindPod Dolphin: 2019-07-05Dolphin 2.0 is an immersive virtual reality software to help motivate people and patients to train complex upper body exploratory movements for both cognitive and motor rehabilitation. Patient assessment, exercise guidance, and approval by the medical professional is required prior to use. The intended users of the Dolphin 2.0 are physiotherapists, occupational therapists, various caregivers and patients. The rehabilitation is targeted at adult patients who have brain injury, stroke or other neurological diseases and are in acute, sub-acute or chronic settings.
• 03760272650026 - MindPod Dolphin: 2019-07-05 Dolphin 2.0 is an immersive virtual reality software to help motivate people and patients to train complex upper body explorator