Duns Number:042826131
Device Description: Low access high-low table is designed for use in hospitals, clinics and private physician Low access high-low table is designed for use in hospitals, clinics and private physician examination rooms. Table has positioning capability to adjust table height and back section of the upholstered couch section by use of a foot control and/or hand control. Low access high-low table is intended to be used for general examinations by qualified medical professionals to position and support patients during procedures.
Catalog Number
4550-06
Brand Name
ENOCHS Examining Room Furniture
Version/Model Number
4550-06
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
LGX
Product Code Name
Table, Examination, Medical, Powered
Public Device Record Key
75f703dc-037e-4c53-a794-27710fd66b50
Public Version Date
July 23, 2020
Public Version Number
1
DI Record Publish Date
July 15, 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 | 23 |