Duns Number:008124539
Catalog Number
-
Brand Name
DynaRide S 3 Lite Wheelchair 18"x16"-18 Flip Desk Arm ELR
Version/Model Number
10230
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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"
Yes
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K070176
Product Code
IOR
Product Code Name
Wheelchair, Mechanical
Public Device Record Key
faa66a66-262c-4a43-9b99-d7b282011db3
Public Version Date
July 02, 2019
Public Version Number
1
DI Record Publish Date
June 24, 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 | 694 |
2 | A medical device with a moderate to high risk that requires special controls. | 226 |
3 | A medical device with high risk that requires premarket approval | 2 |