Duns Number:874709348
Device Description: DALTON AIRPORT BOARDING WHEELCHAIR, WITH ANTI-TIP CASTER, SEAT BELT & LEG RESTRAINT. WT. L DALTON AIRPORT BOARDING WHEELCHAIR, WITH ANTI-TIP CASTER, SEAT BELT & LEG RESTRAINT. WT. LIMIT: 300 LBS.
Catalog Number
-
Brand Name
DALTON AIRPORT BOARDING WHEELCHAIR
Version/Model Number
K09FX13F
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"
Yes
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
05530638-8886-44ef-a306-c3a49ef37f84
Public Version Date
April 09, 2019
Public Version Number
1
DI Record Publish Date
April 01, 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 | 66 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 57 |