Duns Number:252468293
Device Description: The Invisia Corner Seat is a high quality, commercial grade shower seat. The Invisia Corne The Invisia Corner Seat is a high quality, commercial grade shower seat. The Invisia Corner Seat is intended to provide shower seating support for people with reduced mobility. The Invisia Corner Seat is installed with appropriate fasteners to a structural wall. The maximum user weight for this product is 500lbs / 227kgs. Note: Product is not intended to support full body weight (i.e. do not stand on the seat).
Catalog Number
03421
Brand Name
Invisia™ Corner Seat (Matte Black, Honey Stain)
Version/Model Number
INV-WSCS-HNY-BLK
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
-
Product Code
IKX
Product Code Name
Aid, Transfer
Public Device Record Key
324ae5a2-1c3d-411d-8bc9-f40c63019a9e
Public Version Date
September 08, 2021
Public Version Number
1
DI Record Publish Date
August 31, 2021
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 | 298 |