Duns Number:874709348
Device Description: WHEELCHAIR, MANUAL, LIGHT WEIGHT, W/FOOTREST, ADJUSTABLE ARM HEIGHT, WT. LIMIT 250LBS, W/A WHEELCHAIR, MANUAL, LIGHT WEIGHT, W/FOOTREST, ADJUSTABLE ARM HEIGHT, WT. LIMIT 250LBS, W/ANTI-TIPPER
Catalog Number
-
Brand Name
DALTON MANUAL WHEELCHAIR
Version/Model Number
K3DK18FTADJ
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
-
Product Code
IOR
Product Code Name
Wheelchair, Mechanical
Public Device Record Key
2d0eda94-8a00-40c6-a55c-23e6eb5c32c2
Public Version Date
April 30, 2020
Public Version Number
1
DI Record Publish Date
April 22, 2020
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 | 66 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 57 |