seca 525

Basic Information

• Brand Name: seca 525
• Primary DI: 04012030016926
• Version / Model: 525
• Catalog Number: 5250021139
• 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: 5
• Public Version Date: 2019-07-03
• Public Version Status: Update
• Public Device Record Key: 0e8e43be-3270-4f3f-a761-ad210478c4b6

Device Description

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 status The 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.

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: Yes
• 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
PUH	Analyzer, Body Composition, Exempt	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	04012030016926	GS1

Customer Contacts

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