510(k) Report

Devices descending from K220217

7 later devices reach Normatec 3 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240122Normatec EliteNormaTec Industries, LP20243—
+1K221666Normatec GoNormaTec Industries, LP20222—
+2K260529Air Compression Massager (HY-1165)Xiamen High Top Electronic Technology Co., Ltd.20260—
+2K251905Normatec Elite HipNormaTec Industries, LP20250—
+2K243206Air compression massager (ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS-A3, ACM-PLUS-A4…Sichuan Qianli-Beoka Medical Technology, Inc.20250—
+2K243177Sacs ProElastimed, Ltd.20240—
+2K241446Air Compression Massager (ACM-A1, ACM-A2, ACM-A3, ACM-A4)Sichuan Qianii-Beoka Medical Technoiogy Lnc.20240—