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IR Wireless Foot Switch

by Linemaster Switch Corp.

510(k) K053510

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK053510 Date20 Mar 2006ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-0939-2011 FDA Unclassified (pre-2012) initiated 21 Dec 2010

    Surgical equipment, activated by a wireless foot switch, may remain powered on when switch is no longer depressed.

    • Terminated Z-0933-2008 FDA Unclassified (pre-2012) initiated 28 Dec 2007

    Failure to shut-off: Surgical equipment, activated by a wireless foot switch with VASER system, may remain powered on when switch is no longer depressed.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GEI
Device Class
Class II
Regulation
21 CFR Part 878.4400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The IR Wireless Foot Switch is a wireless foot-operated control device designed for hands-free operation in medical and industrial settings. Classified as a general-purpose foot switch (product code GEI), it transmits signals via infrared technology to activate or control connected equipment without physical cables.

This device is supplied as a reusable, non-sterile unit with an infrared wireless transmission range of up to 50 feet. It is intended for use in environments where cord management is a concern, such as operating rooms or clinical examination spaces. Authorized under FDA 510(k) clearance (K053510), it adheres to traditional review standards and is intended for general plastic surgery applications as per advisory committee classification.

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the IR Wireless Foot Switch designed for?

    The IR Wireless Foot Switch is engineered for hands-free operation in medical and industrial environments where cable management is challenging. Its infrared wireless technology allows users to activate or control connected equipment without physical cords, making it ideal for spaces like operating rooms or clinical examination areas.

  • How is the IR Wireless Foot Switch supplied and what does that mean for its use?

    The device is supplied as a reusable, non-sterile unit. This means it is intended for repeated use across multiple patients or applications, but it should not be sterilized or used in sterile procedures. Users should follow manufacturer guidelines for cleaning and maintenance to ensure proper functionality and hygiene.

  • What is the maximum range for the wireless signal of this foot switch?

    The IR Wireless Foot Switch features an infrared wireless transmission range of up to 50 feet. This range allows for flexible positioning of the switch relative to the equipment it controls, reducing the need for physical cables and improving workflow in confined spaces.

  • Is the IR Wireless Foot Switch intended for single-use or reusable applications?

    This foot switch is explicitly designed for reusable applications. It is not intended for single-use and is built to withstand repeated use in medical and industrial settings. However, since it is non-sterile, it should not be used in sterile environments or procedures.

  • What regulatory pathway does the IR Wireless Foot Switch follow?

    The IR Wireless Foot Switch has been authorized under the FDA 510(k) clearance process, specifically under clearance number K053510. It was classified under the General, Plastic Surgery advisory committee (SU) and determined to be substantially equivalent to a predicate device through traditional review standards. This classification aligns with its intended use in general plastic surgery applications.