Duns Number:170562396
Device Description: Stainless Steel 20" seat width - transport chair, 12-1/2" rear wheels, 300lb. capacity, l Stainless Steel 20" seat width - transport chair, 12-1/2" rear wheels, 300lb. capacity, less front rigging, Green
Catalog Number
-
Brand Name
Assembly Required Distributors O+Inc.
Version/Model Number
WCM2025NF50
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"
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
K973418
Product Code
IOR
Product Code Name
Wheelchair, Mechanical
Public Device Record Key
2367e904-7d6d-45bb-865b-af18723639bf
Public Version Date
April 19, 2022
Public Version Number
1
DI Record Publish Date
April 11, 2022
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 |