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Mega Soft Reusable Patient Return Electrode

by Megadyne Medical Products, Inc.

510(k) K080741

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

3 ongoing

This device is named in the recall

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 NumberK080741 Date16 Dec 2008ClearedStatusActive

Recalls

3 recalls · 3 ongoing · FDA

    • Ongoing Z-2248-2024 FDA Class I initiated 17 Jun 2024

    To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns identified with use of Mega Soft pads.

    • Ongoing Z-1920-2024 FDA Class I initiated 8 May 2024

    Reports of patient burns.

    • Ongoing Z-1997-2023 FDA Class I initiated 1 Jun 2023

    Firm has received reports of patient burns in surgical procedures where device was used.

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  • Withdrawn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 Mega Soft Reusable Patient Return Electrode is a reusable electrode designed for use in electrotherapy applications, including electrocautery and electrostimulation procedures. Classified under product code GEI (General and Plastic Surgery Electrodes), it serves as a return electrode to complete the circuit in electrical medical devices. Its construction allows for repeated use over an extended period, reducing waste and operational costs compared to single-use alternatives. The device is intended for attachment to the patient’s skin to facilitate safe and effective electrical current flow during therapeutic or surgical interventions.

This reusable electrode is supplied sterile and intended for use in clinical settings where electrotherapy is administered. It is designed for repeated use up to 24 months with proper maintenance, offering a cost-effective and environmentally friendly alternative to disposable electrodes. The device is radiolucent, ensuring compatibility with X-ray imaging, and latex-free, reducing allergy risks. Storage and handling follow standard reusable medical device protocols, including cleaning and sterilisation between uses. Its FDA_510K clearance (K080741) confirms compliance with regulatory standards for reusable electrodes in electrotherapy applications.

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