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EasyStand Evolv

FDA 510(k)

Class II (US FDA 510(k))

510(k) K062402

by Invacare Corp.

Identifiers

510(k) Number
K062402 FDA 510(k)
FDA Product Code
INO FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 890.3110 FDA 510(k)
Regulation Number
890.3110 FDA 510(k)
Advisory Committee
Physical Medicine FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The EasyStand Evolv is an electric positioning chair designed for physical medicine applications. It assists patients in achieving and maintaining an upright standing position, supporting mobility and functional independence for individuals with limited mobility or strength.

This modular device is configured for single-use or reusable applications in clinical settings, such as physical therapy or rehabilitation facilities. It features multiple adjustable components and over 60 positioning options, allowing customization for individual patient needs. The device is classified under FDA regulation number 890.3110 and holds a 510(k) clearance (K062402) for substantial equivalence. Storage and maintenance instructions are provided by the manufacturer.

Frequently asked questions

What types of clinical settings is the EasyStand Evolv designed for, and how does its modularity benefit patients?

The EasyStand Evolv is specifically designed for physical medicine applications, making it ideal for physical therapy or rehabilitation facilities where mobility support is critical. Its modular design allows for over 60 adjustable positioning options, enabling customization to meet individual patient needs. This flexibility helps clinicians tailor the chair to patients with varying mobility limitations or strength levels, promoting functional independence and comfort during use.

Can the EasyStand Evolv be used repeatedly in a clinical setting, or is it intended for single-use only?

The EasyStand Evolv is configured for both single-use and reusable applications in clinical settings. This versatility allows facilities to choose the most practical option based on their workflow, patient volume, and infection control protocols. The manufacturer provides storage and maintenance instructions to support its reuse when appropriate.

What regulatory pathway was followed for the EasyStand Evolv, and how does this affect its use in physical medicine?

The EasyStand Evolv received FDA 510(k) clearance (K062402) under the classification 890.3110, demonstrating substantial equivalence to a predicate device. This regulatory route confirms its compliance with U.S. safety and performance standards for electric positioning chairs in physical medicine, ensuring it meets clinical requirements for assisting patients in achieving upright standing positions.

How many adjustable positioning options does the EasyStand Evolv offer, and why is this important for patients?

The EasyStand Evolv features over 60 adjustable positioning options, allowing clinicians to fine-tune the chair’s configuration for patients with diverse mobility needs. This extensive customization helps accommodate varying body types, conditions, and functional limitations, enhancing patient comfort, safety, and engagement during therapy or daily use.

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: Everything Evolv - EasyStand, EasyStand - Standing Made Easy, FDA Browser - Cleared 510 (K) - EASYSTAND EVOLV (K062402)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Invacare Corp.

Sources (1)

  • FDA 510(k) K062402 24 fields · synced Sep 19, 2026