510(k) Report

Devices descending from K062198

6 later devices reach Sunspots Pre-Gelled Surface Electrodes through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120494Disposable Adhesive Surface ElectrodeSpes Medica Srl20120—
+1K110289Friendship Medical Disposable Pre-Gelled AG / Agcl Surface ElectrodeXian Friendship Medical Electronics Co., Ltd.20112—
+1K081871Universal ElectrodesNeurometrix, Inc.20081—
+2K142159Disposable Pre-Gelled Surface ElectrodeRochester Electro Medical, Inc.20151—
+2K083818Universal ElectrodesNeurometrix, Inc.20090—
+3K172703Disposable Snap ElectrodeEmbla Systems20170—