Duns Number:259777209
Device Description: Maxx MPSS Stander System
Catalog Number
MPSS
Brand Name
MODULAR POWER STANDING SYSTEM
Version/Model Number
MPSS
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K191376
Product Code
ITI
Product Code Name
Wheelchair, Powered
Public Device Record Key
60eaca79-6a92-4367-9e59-cc3e290bdbd0
Public Version Date
August 20, 2021
Public Version Number
1
DI Record Publish Date
August 12, 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. | 176 |