510(k) Report

Devices descending from K014012

21 later devices reach Doc Band through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140353Starband and StarlightOrthomerica Products, Inc.201413—
+1K072566Hanger Cranial BandHanger Prosthetics & Orthotics, Inc.200820—
+2K203134Hanger Cranial Band 3DSymbion Logistics, LLC20220—
+2K142141Starband, StarlightOrthomerica Products, Inc.20151—
+2K141842Starband, StarlightOrthomerica Products, Inc.201410—
+2K133397P-PODP-Pod20141—
+2K111609Boston BandBoston Brace Intl., Inc.201116—
+2K090341Michigan Cranial Reshaping OrthosisDanmar Products, Inc.20100—
+3K193383SnugKapHeadstart, Ltd.20210—
+3K203098STARband, STARlight, St. Louis BandOrthomerica Products, Inc.20210—
+3K151147STARband, STARlightOrthomerica Products, Inc.20159—
+3K124023StarbandOrthomerica Products, Inc.201315—
+4K151979STARband, STARlightOrthomerica Products, Inc.20158—
+4K133250StarlightOrthomerica Products, Inc.201414—
+5K220681Talee, Talee PostOPInvent Medical USA, LLC20222—
+5K180109STARband, STARlight, St. Louis BandOrthomerica Products, Inc.20183—
+5K161138St. Louis BandOrthomerica Products, Inc.20164—
+6K230444Talee, Talee PostOpInvent Medical USA, LLC20231—
+6K213587MyCRO BandOtto Bock Healthcare LP20220—
+6K201426MyCRO BandOtto Bock Healthcare LP20210—
+7K241957Talee, Talee PostOpInvent Medical USA, LLC20240—