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Model #1555 Remote Joystick

FDA 510(k)

Class II (US FDA 510(k))

510(k) K880364

by Invacare Corp.

Identifiers

510(k) Number
K880364 FDA 510(k)
FDA Product Code
ITI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 890.3860 FDA 510(k)
Regulation Number
890.3860 FDA 510(k)
Advisory Committee
Physical Medicine FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Model #1555 Remote Joystick is a manual control device designed for powered wheelchairs. It enables users to operate wheelchair propulsion systems via a handheld joystick, facilitating independent mobility for individuals with limited upper-body function. This device is classified as a powered wheelchair accessory and is intended to enhance maneuverability and accessibility in various environments.

The Model #1555 Remote Joystick is supplied as a reusable device and is not intended for single-use. It is regulated under FDA 510(k) clearance (K880364) with a classification of Class II, falling under regulation 890.3860. The device is intended for use in physical medicine settings and is not specified for MRI compatibility. No details regarding sterility or packaging are provided in the data. Authorized by Invacare Corp., it was cleared as substantially equivalent in 1988.

Frequently asked questions

What is the Model #1555 Remote Joystick used for?

The Model #1555 Remote Joystick is designed as a manual control device for powered wheelchairs. It allows users with limited upper-body function to operate wheelchair propulsion systems independently, improving mobility and accessibility in various environments. This accessory is specifically intended to enhance maneuverability for individuals who rely on powered wheelchairs.

Is the Model #1555 Remote Joystick reusable or single-use?

The Model #1555 Remote Joystick is explicitly supplied as a reusable device. Unlike single-use accessories, this joystick is intended for repeated use by the same user or across multiple users in a clinical or home setting, provided it is properly maintained and cleaned according to manufacturer guidelines.

What regulatory approval does the Model #1555 Remote Joystick hold?

The Model #1555 Remote Joystick holds FDA 510(k) clearance under the classification of Class II, regulated under FDA regulation number 890.3860. It was cleared as substantially equivalent in 1988 and is authorized for use in physical medicine settings. This clearance indicates that the device meets FDA standards for safety and effectiveness.

Is the Model #1555 Remote Joystick compatible with MRI environments?

The Model #1555 Remote Joystick is not specified for MRI compatibility. Users should consult with their healthcare provider or MRI facility to determine if the device can be safely used in an MRI environment, as non-MRI-compatible accessories may pose risks during imaging procedures.

How is the Model #1555 Remote Joystick supplied, and what should be considered for storage?

The Model #1555 Remote Joystick is supplied as a reusable device, but specific details regarding packaging or sterility are not provided in the available data. For storage, it should be kept in a clean, dry environment away from direct sunlight or extreme temperatures to prevent damage. Since it is reusable, proper cleaning and maintenance are essential to ensure functionality and hygiene.

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: MODEL #1555 REMOTE JOYSTICK (K880364) — FDA 510(k) | Innolitics, PDF K880364 - Model #1555 Remote Joystick, MODEL #1555 REMOTE JOYSTICK 510(k) K880364 - FDA.report, K880365 FDA 510(k) - MODEL #1556 HEAVY-DUTY JOYSTICK

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Invacare Corp.

Sources (1)

  • FDA 510(k) K880364 24 fields · synced Oct 1, 2026