510(k) Report

Devices descending from K240122

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251905Normatec Elite HipNormaTec Industries, LP20250—
+1K243206Air compression massager (ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS-A3, ACM-PLUS-A4…Sichuan Qianli-Beoka Medical Technology, Inc.20250—
+1K241446Air Compression Massager (ACM-A1, ACM-A2, ACM-A3, ACM-A4)Sichuan Qianii-Beoka Medical Technoiogy Lnc.20240—