Duns Number:316584937
Device Description: The Medical Body Composition Analyzer seca 514 is mainly used in hospitals, medical practi The Medical Body Composition Analyzer seca 514 is mainly used in hospitals, medical practices and inpatient care facilities in accordance with national regulations.The mBCA seca 514 measures body Weight and records body Height for calculation of Body Mass Index (BMI), Resting Energy Expenditure (REE) and Total Energy Expenditure (TEE) to monitor growth process and weight changes in individuals of all ages.In healthy individuals aged 18 years and older the BIA function of the device (BIA = Bioelectric Impedance Analysis) allows further parameters such as fatfree mass (FFM) to be estimated automatically. The results are displayed graphically and assist the attending physician with the following medicalaspects:• Assessing energy reserves and energy consumption• Determining the fitness level and metabolic activity• Determining fluid status• Obtaining an overview of body composition and comparing to a healthy populationThe seca 514 is not a diagnostic device. To make an accurate diagnosis, in addition to the results of the seca 514, targeted examinations have to beordered by the physician and their results taken into account.
Catalog Number
5142521139
Brand Name
seca 514
Version/Model Number
514
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K122388
Product Code
MNW
Product Code Name
Analyzer, Body Composition
Public Device Record Key
7f3ba1fa-c5d4-4638-a2f6-51d984c24ec2
Public Version Date
February 21, 2020
Public Version Number
10
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 |