510(k) Report

Devices descending from K080741

4 later devices reach Mega Soft Reusable Patient Return Electrode through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133726Mega Soft Universal Patient Return ElectrodeMegadyne Medical Products, Inc.20143Class I
+2K233644Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne Patient…Megadyne Medical Products, Inc.20240Class I
+2K210727HotDog Warming Mattress + Return ElectrodeAugustine Temperature Management, LLC202202
+2K183148OKLand Patient Return Electrode PadAuckland Medical Polymer (Tianjin) Co., Ltd.20200—