Identity
- Trade Name
- seca 514 FDA UDI
- Generic Name
- Bioelectrical body composition analyser FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 514 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- 5142521139 FDA UDI
- Primary DI / UDI-DI
- 04012030013369 FDA UDI
- 510(k) Number
- K122388 FDA UDI
- FDA Product Code
- MNW FDA UDI
- GMDN Term
- Bioelectrical body composition analyser FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2770 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
seca 514 by Seca Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Seca Corp.
Sources (1)
- FDA UDI 7f3ba1fa-c5d4-4638-a2f6-51d984c24ec2 37 fields · synced Jun 8, 2026