Krell Weight & Body Fat Monitoring Scale, Model BFA-8530
by Krell Precision (Yang Zhou) Co., Ltd.
510(k) K081587
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK081587 | Date24 Oct 2008 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- MNW
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2770
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Krell Weight & Body Fat Monitoring Scale, Model BFA-8530, is a body composition analyzer designed to measure weight and body fat percentage. Classified as an Analyzer, Body Composition, it provides quantitative assessments of body composition metrics, supporting clinical evaluations in cardiovascular health assessments. This device operates by utilizing bioelectrical impedance analysis to derive body fat and other compositional data from the user’s weight and impedance measurements.
The scale is intended for use in clinical and home settings, supplied as a reusable, non-sterile device. It is classified under FDA regulation 870.2770 as a Class II medical device, with an FDA 510(k) clearance (K081587) granted under the Traditional clearance type. The device requires proper calibration and maintenance per manufacturer instructions, and its use is governed by the regulatory framework for body composition analyzers. Storage conditions should follow the manufacturer’s guidelines to ensure accurate and reliable performance.
Questions
AI-generated answers, 1 Oct 2026
What clinical applications does the Krell BFA-8530 body fat monitoring scale support?
The Krell BFA-8530 is designed to support clinical evaluations in cardiovascular health assessments by providing quantitative measurements of body composition metrics, including weight and body fat percentage. It uses bioelectrical impedance analysis to derive these metrics, helping clinicians assess risk factors related to cardiovascular disease. This makes it particularly useful in settings where body composition data aids in patient monitoring and treatment planning.
Is the Krell BFA-8530 scale reusable or single-use, and what does that mean for maintenance?
The Krell BFA-8530 is a reusable device, meaning it is intended for repeated use across multiple patients or individuals. Since it is non-sterile, proper cleaning and maintenance per the manufacturer’s instructions are essential to ensure accuracy, reliability, and hygiene. Regular calibration may also be required to maintain performance standards, as outlined in the device’s operational guidelines.
What regulatory approvals does the Krell BFA-8530 body fat monitoring scale hold?
The Krell BFA-8530 has received FDA 510(k) clearance under the Traditional clearance type, with the clearance number K081587. This classification confirms that the device is substantially equivalent to a legally marketed predicate device and meets FDA regulatory requirements for body composition analyzers. The device is classified under FDA regulation 870.2770 as a Class II medical device.
How should the Krell BFA-8530 be stored to ensure accurate performance?
To maintain accurate and reliable performance, the Krell BFA-8530 should be stored according to the manufacturer’s guidelines, which likely include protecting it from extreme temperatures, humidity, and physical damage. Proper storage conditions help preserve the device’s calibration and functionality. Always refer to the manufacturer’s instructions for specific storage recommendations, as improper storage could affect measurement accuracy.
What types of body composition metrics does the Krell BFA-8530 measure?
The Krell BFA-8530 measures weight and body fat percentage using bioelectrical impedance analysis. This technology assesses the body’s resistance to a small electrical current to estimate composition metrics, including fat mass, muscle mass, and other relevant indicators. These measurements support clinical evaluations, particularly in cardiovascular health assessments, by providing insights into body composition that may influence health outcomes.