Bodystat 1500 Body Composition Monitoring Unit
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K082253 FDA 510(k)
- FDA Product Code
- MNW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2770 FDA 510(k)
- Regulation Number
- 870.2770 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Bodystat 1500 Body Composition Monitoring Unit is a hand-held device designed to measure body composition and hydration. It provides accurate statistics for body fat, lean muscle mass, dry lean mass, and hydration levels using modern technology.
This device is intended for use in medical, health, and fitness environments. It features a touch screen interface and can connect to software via USB cable and Bluetooth printer. The Bodystat 1500 has FDA 510(k) clearance with product code MNW and is classified as a Class II device.
Frequently asked questions
What is the Bodystat 1500 Body Composition Monitoring Unit used for?
The Bodystat 1500 is a hand-held device designed to measure body composition and hydration, providing accurate statistics for body fat, lean muscle mass, dry lean mass, and hydration levels in medical, health, and fitness environments.
How is the Bodystat 1500 supplied and what are its connectivity options?
The Bodystat 1500 features a touch screen interface and can connect to software via USB cable and Bluetooth printer, making it versatile for data transfer and printing in various clinical settings.
What is the regulatory status of the Bodystat 1500?
The Bodystat 1500 has FDA 510(k) clearance with product code MNW and is classified as a Class II device, indicating it meets specific regulatory requirements for safety and effectiveness.
Is the Bodystat 1500 reusable or single-use?
The device is designed for repeated use in clinical settings, as it is a monitoring unit rather than a disposable item, though proper cleaning and maintenance protocols should be followed between uses.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Bodystat 1500 touch | Bodystat Website, PDF Bodystat 1500, BODYSTAT 1500 INSTRUCTIONS FOR USE MANUAL Pdf Download, Bodystat 1500 Manuals | ManualsLib
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K082253 | Class II | Active |
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Manufacturer
- Manufacturer
- Bodystat , Ltd.
Sources (1)
- FDA 510(k) K082253 24 fields · synced Sep 26, 2026