seca 514

Basic Information

• Brand Name: seca 514
• Primary DI: 04012030013352
• Version / Model: 514
• Catalog Number: 5141321139
• Company Name: seca GmbH & Co. KG
• Labeler DUNS: 316584937
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-15
• Public Version: 10
• Public Version Date: 2020-02-21
• Public Version Status: Update
• Public Device Record Key: 67b97a23-f2fa-4e9a-838e-779678cdcc0a

Device Description

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 medical aspects: • 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 population The 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 be ordered by the physician and their results taken into account.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MNW	Analyzer, Body Composition	Cardiovascular	870.2770	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36022	Bioelectrical body composition analyser	An electronic device designed to estimate body composition (i.e., percent body fat, lean, bone, and/or hydration) with regards to bioelectrical impedance analysis (BIA) and often personal characteristics (e.g., age, gender, height, weight). It may be in the form of a unit with electrodes applied to the surface of the patient’s body, or a scale(s) placed on the floor and upon which the patient stands to measure total body weight. Both types perform BIA by passing a low electrical current through the body; personal characteristics may be manually entered. Data are analysed to provide measurements that may include body mass index (BMI), fat/muscle/bone mass, and total body water percent.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04012030013352	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K122388	000