NA
FIAB SPA · Model PG479/50W/US · UDI-DI 08054242447828
GXY
Prescription
1
510(k) clearances
529
Adverse events (1 deaths)
20
Recalls
250
Facilities
Description
PG479/50W/US are round-shaped disposable adhesive electrodes with solid conductive gel. High material flexibility permits to apply electrodes very easily on treating areas. Solid gel maintains unchanged the electrode adhesion and conductivity, during procedure. The electrodes Ø 50 mm are equipped with a 10 cm long cable, with 2mm socket. The electrodes are passive devices serving as interface between transcutaneous neurostimulation devices and the patient’s skin. The electrodes are non-sterile and for single patient use only. Latex free.
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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Get your free API keyRead the docsData 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.