Duns Number:752816785
Device Description: Magic 360 Two Wheel Drive Electric Wheelchair
Catalog Number
Magic 360
Brand Name
Magic 360 Electric Wheelchair
Version/Model Number
360
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 01, 2021
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K203083
Product Code
ITI
Product Code Name
Wheelchair, Powered
Public Device Record Key
ade5ddeb-b75b-4063-ba06-5ed12ff469de
Public Version Date
June 07, 2021
Public Version Number
1
DI Record Publish Date
May 28, 2021
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 8 |