510(k) Report

Devices descending from K082011

14 later devices reach Medistim XP, Type 281 and Meditens XP, Type 458 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193275Nerve and Muscle StimulatorShenzhen Xft Medical Limited20202—
+1K150413QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve StimulatorCymedica Orthopedics, Inc.20157—
+1K112258Neurotech PlusBio-Medical Research, Ltd.20120—
+1K110350Kneehab XPBio-Medical Research, Ltd.20119—
+2K223027NeuroTrigger Basic (NTB)Neurotrigger20230—
+2K212832TimeWaver FrequencyTimewaver Production GmbH20211—
+2K201431OGYILI TENS/NMES StimulatorGongguan Tutamen Metalwork Co., Ltd.20200—
+2K191587L360 Thigh SystemBioness, Inc.20190—
+2K163067CyMedica e-vive™ System; CY-1000Cymedica Orthopedics, Inc.20164—
+3K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+3K210674Shoulder PacemakerNcs Lab Srl20211—
+3K210604Intellihab SystemCymedica Orthopedics, Inc.20211—
+4K220994Shoulder PacemakerTMNcs Lab Srl20220—
+4K220738Motive Knee WrapCymedica Orthopedics, Inc.20220—