510(k) Report

Devices descending from K040253

13 later devices reach Easy Med TN-28 C through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140168Easystim TN28_OtcEasymed Instruments Co., Ltd.20146—
+1K082377Tenscare Itouch Model (S) Easy and PlusTenscare, Ltd.20090—
+1K083494Ultima FivePain Management Technologies20090—
+1K050921Easystim NMS-28Easy Med Instrument Co., Ltd.20053—
+2K183288Transcutaneous Electrical Nerve StimulatorShenzhen Kentro Medical Electronics Co., Ltd.20191—
+2K150043Transcutaneous Electrical Nerve Stimulators (TENS)Andon Health Co, Ltd.20151—
+2K143430SmartTENSEasy Med Instrument Co., Ltd.20151—
+2K120054Ultima NeoPain Management Technologies20122—
+3K232441Unipro (K-UNIPRO-US)Tenscare, Ltd.20241—
+3K222867AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)Andon Health Co, Ltd.20220—
+3K200237Transcutaneous Electronic Nerve StimulatorShenzhen Kentro Medical Electronics Co., Ltd.20200—
+3K190009Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)Hong Qiangxing (Shenzhen) Electronics Limited20190—
+4K252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLC20250—