Duns Number:007941230
Device Description: Standard Wheelchair Swingaway Footrest Fixed Full Padded Armrest 18X16 Inch Seat 300lb We Standard Wheelchair Swingaway Footrest Fixed Full Padded Armrest 18X16 Inch Seat 300lb Weight Capacity Chrome-plated Carbon Steel Frame Flame-resistant Black Vinyl Upholstery Adjustable Height For Foot Propulsion Not Made With Natural Rubber Latex MediChoice
Catalog Number
-
Brand Name
MediChoice
Version/Model Number
WC2002
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
K052468
Product Code
IOR
Product Code Name
Wheelchair, mechanical
Public Device Record Key
4ff3c8a7-992c-4b53-9321-7ecdddd87f1b
Public Version Date
September 29, 2020
Public Version Number
1
DI Record Publish Date
September 21, 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 | 428 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8754 |
| U | Unclassified | 1 |