Body Fat Analyzer HBF-306
510(k) K011652
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK011652 | Date7 Nov 2001 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Body Fat Analyzer, Model Hbf-306
- 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, 19 Sep 2026
The Body Fat Analyzer HBF-306 is a medical device classified as a Body Composition Analyzer, designed to measure body fat percentage, body mass, and related metrics. It employs bioelectrical impedance analysis to assess body composition by passing a small electrical current through the body and analyzing the resistance.
This device is intended for home or clinical use and is supplied as a non-sterile, reusable electronic scale. It has received FDA 510(k) clearance under the Traditional pathway, with a classification of Class II. The HBF-306 operates within standard MRI safety guidelines for non-MRI environments and requires proper storage in a dry, temperature-controlled environment to maintain functionality.
Other devices from Omron Healthcare, Inc.
Questions
AI-generated answers, 19 Sep 2026
How does the Body Fat Analyzer HBF-306 differ from a standard electronic scale in terms of functionality and intended use?
The HBF-306 is specifically designed as a Body Composition Analyzer, not just a scale. Unlike standard electronic scales, it uses bioelectrical impedance analysis (BIA)—a method that passes a small electrical current through the body—to measure not only weight but also body fat percentage, muscle mass, and other composition metrics. This makes it suitable for tracking health-related body composition trends, whereas a standard scale only provides weight measurements.
Is the HBF-306 safe to use in environments where MRI machines are present, and how should it be stored?
The HBF-306 is not MRI-compatible for use inside MRI environments, but it operates safely in non-MRI areas. For proper functionality and longevity, it must be stored in a dry, temperature-controlled environment to prevent damage from moisture or extreme temperatures.
Can the HBF-306 be reused across multiple patients, and if so, what cleaning or maintenance is required?
Yes, the HBF-306 is non-sterile and reusable, meaning it can be used for multiple patients. However, since it is an electronic device, it should be cleaned regularly with mild, non-abrasive cleaners to remove dirt or moisture between uses. Avoid submerging it in water or using harsh chemicals, as this could damage the electrical components.
What regulatory pathway was followed for FDA clearance of the HBF-306, and what does this mean for its safety and performance?
The HBF-306 received FDA 510(k) clearance under the Traditional pathway, meaning it was determined to be substantially equivalent to a legally marketed device already on the market. This pathway ensures that the device meets FDA safety and performance standards, but it does not imply ongoing clinical trials—only that it complies with existing regulatory requirements for body composition analyzers.