510(k) Report

Devices descending from K131921

6 later devices reach Electronic Pulse Stimulator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141260Electronic Pulse StimulatorShenzhen Jingkehui Electronic Co.., Ltd.20145—
+2K200561StimPlus Patch, StimPlus Patch, StimPlus PatchJkh Health Co., Ltd.20202—
+2K182671Medi-Direct TENS PenJkh USA, LLC20190—
+2K170145Digital TENS UnitShenzhen Eapply Technology Co., Ltd.20170—
+3K211942Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B)Shenzhen Osto Technology Company Limited20211—
+4K223428Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A…Shenzhen Leqing Medical Instrument Co., Ltd.20230—