Duns Number:252468293
Device Description: The Invisia Bath Bench is a high quality, commercial grade bath seat. The Invisia Bath Ben The Invisia Bath Bench is a high quality, commercial grade bath seat. The Invisia Bath Bench is intended to provide shower seating support for people with reduced mobility.The Invisia Bath Bench rests across the top surface of the bathtub rim, and rubber feet provide friction to reduce horizontal shifting. 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). The Invisia Bath Bench is not to be used in any other way than described above. The Invisia Bath Bench is made from robust materials and is capable of supporting vigorous forces during proper / normal usage. The structural components of the seat are made from wood (laminated bamboo).
Catalog Number
03114
Brand Name
Invisia™ BathBench (Matte Black, 30"/762mm, Walnut Stain)
Version/Model Number
INV-WSBB-30-WNT-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"
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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
22100395-c970-4b89-8a2a-9db11b96d36d
Public Version Date
September 07, 2021
Public Version Number
1
DI Record Publish Date
August 30, 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 |