Duns Number:486449510
Device Description: MindPod Dolphin is immersive serious gaming software for adult patients and healthy partic MindPod Dolphin is immersive serious gaming software for adult patients and healthy participants. MindPod Dolphin motivates patients and participants to make high-intensity and high-dose non-task oriented upper-body exploratory movements in a challenging and beautiful environment. This targets motor and cognitive rehabilitation and provides a form of exercise. The experience can be provided under either continuous or intermittent supervision by a caregiver.
Catalog Number
-
Brand Name
MindPod Dolphin
Version/Model Number
DLP-01
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ION
Product Code Name
Exerciser, Non-Measuring
Public Device Record Key
a736e37b-ac3a-4a80-b4a2-6aa567e4c0fa
Public Version Date
June 08, 2021
Public Version Number
3
DI Record Publish Date
June 27, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |