Bodystay Impedance Plethysmograph
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K951097 FDA 510(k)
- FDA Product Code
- DSB 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 Bodystay is an impedance plethysmograph, a medical device used to measure changes in volume within body parts, such as limbs or the torso, by detecting variations in electrical impedance. It is classified as a Class II device under FDA regulations and is primarily employed in cardiovascular assessments to evaluate blood flow, venous return, and peripheral circulation. The device operates by applying a low-level electrical current and measuring the resulting impedance changes, which correlate with physiological volume shifts.
The Bodystay is supplied as a reusable medical instrument and is intended for use in clinical settings such as hospitals, research laboratories, or specialized cardiovascular clinics. It requires proper calibration and maintenance to ensure accurate readings. The device is not sterile and must be cleaned and disinfected between uses according to standard infection control protocols. Authorized for use in the United States under an FDA 510(k) clearance (K951097), it adheres to regulatory standards for impedance-based diagnostic equipment, including compliance with 21 CFR 870.2770.
Frequently asked questions
What clinical applications is the Bodystay primarily used for in cardiovascular assessments?
The Bodystay is designed to measure changes in volume within body parts like limbs or the torso by detecting electrical impedance shifts. Clinically, it is used to evaluate blood flow, venous return, and peripheral circulation—key metrics in cardiovascular assessments. This helps clinicians assess circulatory function, particularly in settings like hospitals or specialized cardiovascular clinics.
Is the Bodystay a single-use or reusable device, and what maintenance does it require?
The Bodystay is a reusable medical instrument, meaning it is designed for repeated use in clinical settings. Since it is not sterile, it must be thoroughly cleaned and disinfected between uses following standard infection control protocols. Proper calibration and maintenance are also required to ensure accurate and reliable impedance measurements.
How is the Bodystay regulated in the United States, and what does its clearance status mean?
The Bodystay is authorized for use in the U.S. under an FDA 510(k) clearance (K951097), which means it has been determined to be *substantially equivalent* to a legally marketed device already on the market. This clearance confirms compliance with FDA regulations for impedance-based diagnostic equipment, including adherence to 21 CFR 870.2770, ensuring its safety and performance for cardiovascular assessments.
What types of facilities or settings is the Bodystay intended for, and why?
The Bodystay is intended for use in clinical settings such as hospitals, research laboratories, and specialized cardiovascular clinics. Its design as a reusable instrument with precise impedance measurement capabilities makes it suitable for environments where repeated, accurate assessments of blood flow and circulation are required, such as in diagnostic or research contexts.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K951097 | Class II | Active |
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Manufacturer
- Manufacturer
- Bodystat , Ltd.
Sources (1)
- FDA 510(k) K951097 24 fields · synced Sep 20, 2026