510(k) Report

Devices descending from K152852

2 later devices reach ALEVE Direct Therapy (ALEVE Direct Therapy TENS device) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190009Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)Hong Qiangxing (Shenzhen) Electronics Limited20190—
+1K171802ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)Bayer Healthcare, LLC20180—