510(k) Report

Devices descending from K060222

14 later devices reach Low Back Pain Relief System /Models GM310PP,GM320PP,GM321PP, and GM330PP through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110716Everyway Low Back Pain Relief SystemEveryway Medical Instruments Co.,Ltd20110—
+1K110390Etg 255 Combo Stimualtor, Ten 260 StimualtorHandelshaus Dittman GmbH20110—
+1K090042Painmaster MCT PatchNewmark, Inc.200911—
+2K151995Painmaster MCT PatchNewmark, Inc.20160—
+2K151034PainKARETriowave Technologies20150—
+2K130114Painmaster MCT PatchNewmark, Inc.20135—
+2K120500The Pain Pilot (a.K.a Pain Pilot)Hollywog, LLC20124—
+3K182267PAT (Pain Alleviation Technologies)Marchan Medical, LLC20190—
+3K152852ALEVE Direct Therapy (ALEVE Direct Therapy TENS device)Bayer Healthcare, LLC20152—
+3K133789Dolphin Neurostim OtcAcumed Medical, Ltd.20151—
+3K1335025000Z Firefly SystemPrizm Medical, Inc.20140—
+4K190009Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)Hong Qiangxing (Shenzhen) Electronics Limited20190—
+4K182671Medi-Direct TENS PenJkh USA, LLC20190—
+4K171802ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)Bayer Healthcare, LLC20180—