Duns Number:316584937
Device Description: The seca 525 medical Body Composition Analyzer is mainly used in hospitals, medical practi The seca 525 medical Body Composition Analyzer is mainly used in hospitals, medical practices and inpatient care facilities in accordance with national regulations.The medical Body Composition Analyzer seca 525 records weight, height and bioelectric impedance measurements and automatically calculates parameters such as fat-free mass (FFM) which can be derived from them. The results are displayed in graphical form and assist the attending physician with the following medical issues:• determining energy expenditure and energy reserves as a basis for nutritional advice• assessing metabolic activity and the success of a training program, e.g. within the framework of rehabilitation or physiotherapy• determining a patient's fluids statusThe seca 525 is not a diagnostic device. To make an accurate diagnosis, the physician needs to commission specific examinations and take their results into account in addition to the results of the seca 525.The device is not intended for use on children. For North America: the device is intended for use on healthy individuals from 18 years of age upwards.
Catalog Number
5250021139
Brand Name
seca 525
Version/Model Number
525
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
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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
PUH
Product Code Name
Analyzer, Body Composition, Exempt
Public Device Record Key
0e8e43be-3270-4f3f-a761-ad210478c4b6
Public Version Date
July 03, 2019
Public Version Number
5
DI Record Publish Date
September 15, 2016
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 |