510(k) Report

Devices descending from K954411

5 later devices reach Galva-5-M through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121059Soleoline, Soleo Stim, Soleo Sono, Soleo SonostimZimmer Medizinsystems GmbH20124—
+2K161628JAS Pulse (TM) Ultrasonic TherapyBonutti Research, Inc.20163—
+3K241099Plasonic (Plasonic)Hironic Co., Ltd.20242—
+4K260397SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)Hironic Co., Ltd.20260—
+4K251334New Doublo 2.0Hironic Co., Ltd.20250—