Duns Number:557086410
Device Description: Superstand Standing Wheelchair, manual, folding
Catalog Number
-
Brand Name
SuperStand Standing Wheelchair
Version/Model Number
SS-1F
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K962278
Product Code
IPL
Product Code Name
Wheelchair, Standup
Public Device Record Key
a7a8a1fc-f265-4193-864e-4534ced40e01
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
January 30, 2017
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. | 4 |