510(k) Report

Devices descending from K151834

11 later devices reach BEMER Classic Set, BEMER Pro-Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243165Limfa Therapy System (Limfa Therapy)Eywa Srl20250—
+1K240348Quantum Mitohormesis (QMT) (M2101)Quantumtx Pte., Ltd.20240—
+1K231368Bemer Therapy System EvoBemer Int AG20230—
+1K203710Storz Medical MAGNETOLITH Muscle StimulatorStorz Medical AG20214—
+1K210174BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-SetBemer Int AG20215—
+2K250896Aura WaveAura Wellness, LLC20251—
+2K240234BTL-899MSBTL Industries, Inc.20242—
+2K220938Nova HD+Aura Wellness, LLC20231—
+3K262788Nova HD+Aura Wellness, LLC20260—
+3K253408CoolToneZimmer Medizinsysteme GmbH20260—
+3K251594truFlexSyrma Johari Medtech Limited20250—