Duns Number:042826131
Device Description: High-low treatment table is designed for use in hospitals, clinics and private physician t High-low treatment table is designed for use in hospitals, clinics and private physician treatment/examination rooms. Table has capability to adjust in height by use of a foot control. High-low treatment table is intended to be used for general treatment and/or examination by qualified medical professionals and is designed to raise and support patients during procedures.
Catalog Number
2250
Brand Name
ENOCHS Examining Room Furniture
Version/Model Number
2250
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
96fe610b-14a9-45fb-8979-64ba5b7acec0
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 |