Duns Number:170562396
Device Description: Non-folding 22" WC stainless chair, with 600 lbs cap. Removable desk arm, swing-away heavy Non-folding 22" WC stainless chair, with 600 lbs cap. Removable desk arm, swing-away heavy duty footrests...Seat width 22", seat depth 18"
Catalog Number
-
Brand Name
Assembly Required Distributors
Version/Model Number
INV00531
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
10d1e788-4b51-4920-96b7-c482f347e46b
Public Version Date
July 14, 2020
Public Version Number
1
DI Record Publish Date
July 06, 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 | 81 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |