510(k) Report

Devices descending from K061516

15 later devices reach Staodyn Max Preset, Model 4470 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120398Witouch ProHollywog, LLC20123—
+1K112258Neurotech PlusBio-Medical Research, Ltd.20120—
+1K110350Kneehab XPBio-Medical Research, Ltd.20119—
+2K191587L360 Thigh SystemBioness, Inc.20190—
+2K171599WiTouch Pro, WiTouch, NeubacHollywog, LLC20170—
+2K143430SmartTENSEasy Med Instrument Co., Ltd.20151—
+2K150413QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve StimulatorCymedica Orthopedics, Inc.20157—
+3K212832TimeWaver FrequencyTimewaver Production GmbH20211—
+3K190009Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)Hong Qiangxing (Shenzhen) Electronics Limited20190—
+3K163067CyMedica e-vive™ System; CY-1000Cymedica Orthopedics, Inc.20164—
+4K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+4K210674Shoulder PacemakerNcs Lab Srl20211—
+4K210604Intellihab SystemCymedica Orthopedics, Inc.20211—
+5K220994Shoulder PacemakerTMNcs Lab Srl20220—
+5K220738Motive Knee WrapCymedica Orthopedics, Inc.20220—