Detecto Body Composition Analyzer
by Precision One Lifecare, Ltd.
510(k) K130952
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK130952 | Date26 Sep 2013 | 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- Withdrawn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
- Precision One Lifecare; Detecto; Detecto
- 510(k) Number
- FDA Product Code
- MNW
- Models / Variants
- 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 Detecto Body Composition Analyzer is a bioelectrical impedance analysis (BIA) device designed to measure body composition metrics. It estimates and records body fat percentage, total body water percentage, bone mass percentage, and muscle mass percentage, providing quantitative assessments for clinical or consumer use.
This device is supplied as a non-sterile, reusable medical instrument intended for use in clinical or home settings. It operates under FDA 510(k) clearance (K130952) as a Class II device under regulation 870.2770, categorized under product code MNW. Multiple model/serial reference numbers are associated with its regulatory submission, though specific device sizes or storage requirements are not detailed in the available data.
Questions
AI-generated answers, 19 Sep 2026
What types of body composition metrics does the Detecto Body Composition Analyzer measure, and how might these be useful in clinical or home settings?
The Detecto Body Composition Analyzer measures body fat percentage, total body water percentage, bone mass percentage, and muscle mass percentage using bioelectrical impedance analysis (BIA). These metrics provide quantitative assessments that can help clinicians monitor patient health trends, such as muscle mass loss or fluid retention, while consumers may use them to track fitness progress, hydration levels, or nutritional balance in a home setting.
Is the Detecto Body Composition Analyzer intended for single-use or reusable applications, and what does that mean for maintenance?
The Detecto Body Composition Analyzer is supplied as a non-sterile, reusable medical instrument, meaning it is designed for repeated use in clinical or home settings. Reusability implies it requires proper cleaning and maintenance between uses to ensure accuracy and hygiene, though specific cleaning protocols or shelf-life details are not provided in the available data.
What regulatory pathway was followed for FDA clearance of the Detecto Body Composition Analyzer, and what does this classification imply about its oversight?
The Detecto Body Composition Analyzer received FDA clearance under a 510(k) submission (K130952) as a Class II device under regulation 870.2770, categorized under product code MNW. This classification means it is subject to stricter controls than Class I devices but does not require premarket approval (PMA), indicating it poses moderate risk and undergoes additional scrutiny, such as performance standards or post-market surveillance, to ensure safety and effectiveness.
Are there specific storage requirements mentioned for the Detecto Body Composition Analyzer, and if not, what should users consider?
The available data does not specify storage requirements for the Detecto Body Composition Analyzer. However, as a reusable medical device, users should store it in a clean, dry environment away from direct sunlight or extreme temperatures to prevent damage or contamination. Proper handling and maintenance will also help preserve its accuracy and longevity.