Duns Number:170562396
Device Description: WC 18" seat width, 16" seat depth, flip-up arm,detachable footrests, w/ black/gray nylon o WC 18" seat width, 16" seat depth, flip-up arm,detachable footrests, w/ black/gray nylon open weave seat and back, plastic a/r 250lb capacityINV01426
Catalog Number
-
Brand Name
Assembly Required Distributors
Version/Model Number
INV00794
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
K973418
Product Code
IOR
Product Code Name
Wheelchair, Mechanical
Public Device Record Key
9d6c685b-9c50-45e4-9e1d-9ff5b3967c33
Public Version Date
July 07, 2020
Public Version Number
2
DI Record Publish Date
September 04, 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 | 81 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |