510(k) Report

Devices descending from K013192

11 later devices reach Sonicator Plus 930, Model ME 930 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160378BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS)Brh Medical, Ltd.20170—
+1K131309Sonopulse Compact 1MHZ, Sonopulse Compact 3MHZIbramed Equipamentos Medicos20144—
+1K130888Sonopulse/ Sonopulse IiiIbramed- Industria Brazileria DE Equipamentos Medi20145—
+1K052340DU857 Dual Frequency Ultrasound Therapy and Muscle Stimulator SystemAlfa Tech Medical Systems, Ltd.20052—
+2K202788Sonomed IV, Sonomed VCarci Industria E Comercio DE Aparelhos Cirurgicos E Orto20214—
+2K161628JAS Pulse (TM) Ultrasonic TherapyBonutti Research, Inc.20163—
+2K063728TNN-DU810 Non-Invasive Subdermal Therapy SystemAlfa Tech Medical Systems, Ltd.20070—
+3K241099Plasonic (Plasonic)Hironic Co., Ltd.20242—
+3K230472Sonopuls 190Enraf-Nonius, B.V.20233—
+4K260397SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)Hironic Co., Ltd.20260—
+4K251334New Doublo 2.0Hironic Co., Ltd.20250—