510(k) Report

Devices descending from K183169

10 later devices reach Pulse 2.0, Pulse Pro 2.0 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220217Normatec 3NormaTec Industries, LP20227—
+1K210281Fist Assist Devices Model FA-1Fist Assist Devices, LLC20210—
+1K192358Pressure Therapy System PT1003Xiamen Senyang Co., Ltd.202001
+2K240122Normatec EliteNormaTec Industries, LP20243—
+2K221666Normatec GoNormaTec Industries, LP20222—
+3K260529Air Compression Massager (HY-1165)Xiamen High Top Electronic Technology Co., Ltd.20260—
+3K251905Normatec Elite HipNormaTec Industries, LP20250—
+3K243206Air compression massager (ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS-A3, ACM-PLUS-A4…Sichuan Qianli-Beoka Medical Technology, Inc.20250—
+3K243177Sacs ProElastimed, Ltd.20240—
+3K241446Air Compression Massager (ACM-A1, ACM-A2, ACM-A3, ACM-A4)Sichuan Qianii-Beoka Medical Technoiogy Lnc.20240—