510(k) Report

Devices descending from K994266

20 later devices reach Fdtens 2010 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052813FD Tens 2030, Model DFJ24TFuji Dynamics Limited20062—
+1K041164L-TENSFuji Dynamics Limited20040—
+1K040253Easy Med TN-28 CEasy Med Instrument Co., Ltd.200413—
+1K020846Ultima Tens XL-A1Tenscare, Ltd.20025—
+2K152676FD Tens 2090, FD Tens 2095Fuji Dynamics, Ltd.20160—
+2K140168Easystim TN28_OtcEasymed Instruments Co., Ltd.20146—
+2K111654FD Tens 2070Fuji Dynamics, Ltd.20120—
+2K082377Tenscare Itouch Model (S) Easy and PlusTenscare, Ltd.20090—
+2K083494Ultima FivePain Management Technologies20090—
+2K050921Easystim NMS-28Easy Med Instrument Co., Ltd.20053—
+2K023997Tenscare Ultima NMS/EmsTenscare, Ltd.20034—
+3K183288Transcutaneous Electrical Nerve StimulatorShenzhen Kentro Medical Electronics Co., Ltd.20191—
+3K150043Transcutaneous Electrical Nerve Stimulators (TENS)Andon Health Co, Ltd.20151—
+3K143430SmartTENSEasy Med Instrument Co., Ltd.20151—
+3K120054Ultima NeoPain Management Technologies20122—
+4K232441Unipro (K-UNIPRO-US)Tenscare, Ltd.20241—
+4K222867AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)Andon Health Co, Ltd.20220—
+4K200237Transcutaneous Electronic Nerve StimulatorShenzhen Kentro Medical Electronics Co., Ltd.20200—
+4K190009Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)Hong Qiangxing (Shenzhen) Electronics Limited20190—
+5K252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLC20250—