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Konmed

Shenzhen Konmed Technology Co., Ltd. · Model KM-802 · UDI-DI 06970935830109

GXY

510(k) clearances

530

Adverse events (1 deaths)

Recalls

250

Facilities

Description

The proposed Electrodes with snap / Electrodes with pigtail are non-sterile laminated, flexible structures composed of materials commonly used in this application: The electrodes are designed for single-patient application use. Because of the adhesive nature of the biocompatible hydro gel, no securing materials are required to secure the product to the patient’s skin. The proposed product mainly consists of electrode pad and snap or pigtail. The electrode pad is available in Round Shape Electrode, Rectangular Shape Electrode, Palm Shape Electrode, Elliptical Shape Electrode, and Calabash Shape Electrode. All patient contacted materials are complied with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization).

Recalls

Date	Firm	Reason
2023-10-02	Coapt LLC	Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or warm temperatures for over 12 hours or battery is damaged.
2023-10-02	Coapt LLC	Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or warm temperatures for over 12 hours or battery is damaged.
2022-05-25	Mckesson Medical-Surgical Inc. Corporate Office	Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0
2022-03-14	Neuralynx Inc	Atlas Stim Headbox (ASHB) was delivered to US customers under a premise that the device had an Investigational Device Exemption (IDE) and was for research use only, but the manufa
2014-04-24	Medtronic Navigation, Inc.	Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriate
2014-04-24	Medtronic Navigation, Inc.	Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriate
2012-02-09	Covidien LLC dba Uni-Patch	Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it was determined that during the manufacturing process the surface of the wires in the
2012-02-09	Covidien LLC dba Uni-Patch	Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it was determined that during the manufacturing process the surface of the wires in the
2012-02-09	Covidien LLC dba Uni-Patch	Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it was determined that during the manufacturing process the surface of the wires in the
2012-02-09	Covidien LLC dba Uni-Patch	Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it was determined that during the manufacturing process the surface of the wires in the

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.