510(k) Report

Devices descending from K053214

29 later devices reach Theraknit Garment Electrode through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200942Well-Life Garment Electrodes (GM Series)Well-Life Healthcare Limited20210—
+1K171798Silverwear Silver Pro Garment DeviceMedia Plus, LLC20183—
+1K172887XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro -…Guangzhou Xinbo Electronic Co., Ltd.20180—
+1K171721Electrodes with silver conductiveShenzhen Konmed Technology Co., Ltd.20185—
+1K103719Lifecare Conductive GarmentsEveryway Medical Instruments Co.,Ltd201120—
+1K061343Inspirstar Glove ElectrodeInspirstar, Inc.20060—
+2K232995Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for…Shenzhen Roundwhale Technology Co., Ltd.20240—
+2K203158BioWave BioWrapsBiowave Corporation20212—
+2K123354Revitive IXActegy, Ltd.201319—
+3K261522BioWave BioWrapsBiowave Corporation20260—
+3K171071StimSox (TM) SystemStimmed, LLC20170—
+3K143207Revitive IX (OTC)Actegy, Ltd.201517—
+4K183103EMS Belt (Model MC0485)Dongguan Yingfeng Metal & Plastic Products Co., Ltd.20190—
+4K163611Pain Therapy DeviceGuangzhou Xinbo Electronic Co., Ltd.20172—
+4K160323FlowKeepersDk Electronics, LLC20170—
+4K151834BEMER Classic Set, BEMER Pro-SetBemer Int AG2017111
+5K243165Limfa Therapy System (Limfa Therapy)Eywa Srl20250—
+5K240348Quantum Mitohormesis (QMT) (M2101)Quantumtx Pte., Ltd.20240—
+5K231368Bemer Therapy System EvoBemer Int AG20230—
+5K230443TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)Jiangxi Royall Smart Technology Co., Ltd.20230—
+5K203710Storz Medical MAGNETOLITH Muscle StimulatorStorz Medical AG20214—
+5K210174BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-SetBemer Int AG20215—
+5K200237Transcutaneous Electronic Nerve StimulatorShenzhen Kentro Medical Electronics Co., Ltd.20200—
+6K250896Aura WaveAura Wellness, LLC20251—
+6K240234BTL-899MSBTL Industries, Inc.20242—
+6K220938Nova HD+Aura Wellness, LLC20231—
+7K262788Nova HD+Aura Wellness, LLC20260—
+7K253408CoolToneZimmer Medizinsysteme GmbH20260—
+7K251594truFlexSyrma Johari Medtech Limited20250—