Duns Number:316584937
Device Description: Chair scale to weigh seated patients. The seat provides a safe position while the swivelin Chair scale to weigh seated patients. The seat provides a safe position while the swiveling armrests and adjustable footrests make the chair scale more user-friendly. The locking rear wheels ensure that it is safe to sit down and stand up at all times. The positioning of the large LCD display unit behind the chair permits intuitive operation of functions TARE, HOLD and BMI.
Catalog Number
9541309007
Brand Name
seca 954
Version/Model Number
954
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
FRI
Product Code Name
SCALE, STAND-ON, PATIENT
Public Device Record Key
43cbd2c2-4914-47ad-a52d-c1fd2280bdac
Public Version Date
September 17, 2018
Public Version Number
1
DI Record Publish Date
August 15, 2018
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 | 109 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 29 |
| U | Unclassified | 3 |