510(k) Report

Devices descending from K090042

11 later devices reach Painmaster MCT Patch through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151995Painmaster MCT PatchNewmark, Inc.20160—
+1K151034PainKARETriowave Technologies20150—
+1K130114Painmaster MCT PatchNewmark, Inc.20135—
+1K120500The Pain Pilot (a.K.a Pain Pilot)Hollywog, LLC20124—
+2K182267PAT (Pain Alleviation Technologies)Marchan Medical, LLC20190—
+2K152852ALEVE Direct Therapy (ALEVE Direct Therapy TENS device)Bayer Healthcare, LLC20152—
+2K133789Dolphin Neurostim OtcAcumed Medical, Ltd.20151—
+2K1335025000Z Firefly SystemPrizm Medical, Inc.20140—
+3K190009Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)Hong Qiangxing (Shenzhen) Electronics Limited20190—
+3K182671Medi-Direct TENS PenJkh USA, LLC20190—
+3K171802ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)Bayer Healthcare, LLC20180—