510(k) Report

Devices descending from K844385

27 later devices reach Escotek Est Trac 401 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071347Vax-D Genesis G2 SystemVax-D Medical Technologies, LLC20071—
+1K053223Triton/Tru-Trac/TX/Triton DTS TractionChattanooga Group20068—
+1K022602DRX3000Axiom Usa., Inc.20034—
+1K023160DRX5000Axiom Usa., Inc.20024—
+1K992733Akron ATP9 Traction MachineHuntleigh Technology, Inc.19999—
+1K981822DRS SystemProfessional Distribution Systems, Inc.199816—
+2K243366DRX9000C-SL Cervical Spinal Decompression SystemExcite Medical of Tampa Bay, LLC20250—
+2K214037Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-TracErgo-Flex Technologies, LLC20240—
+2K151640Eltrac 471Enraf-Nonius, B.V.20151—
+2K150695ModpodHollywog, LLC20150—
+2K103248Integrity Spinal Care SystemIntegra Life Sciences20110—
+2K101889Decompression of Choice and Neuro Decompression DevicePivotal Health Solutions201001
+2K091540MTD 4000Mettler Electronics Corp.200901
+2K081247TM-400Ito Co., Ltd.20080—
+2K072064Gravilax Traction SystemTherapeutic Clinical Technologies, Inc.20080—
+2K073132Model D Disc ForceNorth American Medical Corp (Nam)20080—
+2K073542Cycletrac CT-5000Pt Products, LLC200802
+2K060735DRX9000 True Spinal Decompression SystemAxiom Worldwide, Inc.20063—
+2K051013Spinemed S200B/S200CCert Health Sciences, LLC20050—
+2K042482Bass Antalgic-TrakTraction Masters, LLC20050—
+2K043239Healthstar EliteHill Laboratories Co.20040—
+2K031862Spinerx-LDMSpinerx Technology20039—
+2K030060SpinemedCert Health Sciences, LLC200310—
+2K992545TM-300 Traction SystemIto Co., Ltd.199921
+3K243775True Non-Surgical Spinal Decompression System (DRX9000-SL)Excite Medical of Tampa Bay, LLC20250—
+3K222912c1TracZimmer Medizinsysteme GmbH20230—
+3K130249Integrity Spinal Care System 3.0Integrity Life Sciences20140—