Duns Number:080798558
Device Description: Alum W/C 20' seat width, dark blue uph. flip up armrests,alum. side panel , w/ footrests Alum W/C 20' seat width, dark blue uph. flip up armrests,alum. side panel , w/ footrests, 300lb capacity
Catalog Number
-
Brand Name
Setmark Incorporated
Version/Model Number
NF-100
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
K973418
Product Code
IOR
Product Code Name
Wheelchair, Mechanical
Public Device Record Key
3bbc32ce-0630-43bb-be02-296b24f8e66a
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
January 31, 2018
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 | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |