Duns Number:316584937
Device Description: This battery-operated digital scale was specially developed to weigh obese patients, with This battery-operated digital scale was specially developed to weigh obese patients, with a weighing range of up to 300 kg. Patients also may be weighed while seated; the weight of the chair is simply deducted with the Pre-TARE function. The cable remote display (cable length: 2.5 m) with easy-toread LCD can be held, mounted on a wall or placed on a table.
Catalog Number
6341321008
Brand Name
seca 634
Version/Model Number
634
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
2101accf-0ff8-499b-94a6-db61811d0584
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 |