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Three degrees
Dong Guan Ou Kang Electronics CO.,LTD · Model Circular · UDI-DI 06976378040020
GXY
Prescription
1
510(k) clearances
530
Adverse events (1 deaths)
20
Recalls
250
Facilities
Description
Circular shape TENS/EMS Electrode Pads includes specification of Φ15, Φ20, Φ22, Φ25, Φ30, Φ32, Φ35, Φ40, Φ45, Φ50, Φ52, Φ55, Φ60, Φ64, Φ65, Φ70, Φ75, Φ80, Φ90, Φ100, Φ110, Φ115, Φ120, Φ130, Φ135, Φ150, Φ160
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.