Equipment, Traction, Powered

FDA product code ITH · 67 cleared devices

Class 2 Physical Medicine

Regulation: 21 CFR 890.5900
Review panel: PM
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-04-08 – 2025-07-18

ITH 2025-07-18

True Non-Surgical Spinal Decompression System (DRX9000-SL)

Applicant Excite Medical of Tampa Bay, LLC

K number K243775

View details →

ITH 2025-06-18

DRX9000C-SL Cervical Spinal Decompression System

Applicant Excite Medical of Tampa Bay, LLC

K number K243366

View details →

ITH 2024-02-22

Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac

Applicant Ergo-Flex Technologies, LLC

K number K214037

View details →

ITH 2023-05-16

c1Trac

Applicant Zimmer Medizinsysteme GmbH

K number K222912

View details →

ITH 2012-02-01

EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800

Applicant Everyway Medical Instruments Co.,Ltd

K number K112074

View details →

ITH 2011-04-05

INTEGRITY SPINAL CARE SYSTEM

Applicant Integra Life Sciences

K number K103248

View details →

ITH 2010-08-27

DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE

Applicant Pivotal Health Solutions

K number K101889

View details →

ITH 2009-10-08

MTD 4000

Applicant Mettler Electronics Corp.

K number K091540

View details →

ITH 2008-08-25

TM-400

Applicant Ito Co., Ltd.

K number K081247

View details →

ITH 2008-04-21

GRAVILAX TRACTION SYSTEM

Applicant Therapeutic Clinical Technologies, Inc.

K number K072064

View details →

ITH 2008-04-03

MODEL D DISC FORCE

Applicant North American Medical Corp (Nam)

K number K073132

View details →

ITH 2008-02-14

CYCLETRAC CT-5000

Applicant Pt Products, LLC

K number K073542

View details →

ITH 2007-10-05

VAX-D GENESIS G2 SYSTEM

Applicant Vax-D Medical Technologies, LLC

K number K071347

View details →

ITH 2007-03-14

CTBOX CERVICAL/LUMBAR TRACTION

Applicant Circular Traction Supply, Inc.

K number K063353

View details →

ITH 2006-05-26

DRX9000 TRUE SPINAL DECOMPRESSION SYSTEM

Applicant Axiom Worldwide, Inc.

K number K060735

View details →

ITH 2006-02-24

TRITON/TRU-TRAC/TX/TRITON DTS TRACTION

Applicant Chattanooga Group

K number K053223

View details →

ITH 2006-01-13

TRACTION SYSTEM, DIGIT-TRAC 930

Applicant Ever Prosperous Instrument, Inc.

K number K052453

View details →

ITH 2005-12-28

VAX-D GENESIS SYSTEM (THERAPEUTIC TABLE)

Applicant Vax-D Medical Technologies USA, L.C.

K number K053503

View details →

ITH 2005-09-21

TRITON/TRU-TRAC/TX TRACTION DEVICES

Applicant Chattanooga Group

K number K051938

View details →

ITH 2005-09-09

SPINA SYSTEM

Applicant North American Medical Corp (Nam)

K number K033231

View details →

ITH 2005-04-27

SPINEMED S200B/S200C

Applicant Cert Health Sciences, LLC

K number K051013

View details →

ITH 2005-03-21

BASS ANTALGIC-TRAK

Applicant Traction Masters, LLC

K number K042482

View details →

ITH 2004-12-22

HEALTHSTAR ELITE

Applicant Hill Laboratories Co.

K number K043239

View details →

ITH 2004-07-23

EXTENTRAC ELITE

Applicant Advanced Back Technologies

K number K031996

View details →

ITH 2003-10-31

SPINERX-LDM

Applicant Spinerx Technology

K number K031862

View details →

ITH 2003-07-17

LORDEX POWER TRACTION EQUIPMENT

Applicant Ever Prosperous Instrument, Inc.

K number K031227

View details →

ITH 2003-02-05

SPINEMED

Applicant Cert Health Sciences, LLC

K number K030060

View details →

ITH 2003-01-23

DRX3000

Applicant Axiom Usa., Inc.

K number K022602

View details →

ITH 2002-12-20

DRX5000

Applicant Axiom Usa., Inc.

K number K023160

View details →

ITH 2001-05-01

DRX 2000

Applicant Axiom Worldwide, Inc.

K number K010292

View details →

ITH 2000-08-31

3D ACTIVETRAC

Applicant The Saunders Group

K number K001712

View details →

ITH 2000-08-25

SPINA SYSTEM

Applicant North American Medical Corporation (Nam)

K number K002260

View details →

ITH 2000-07-19

JILCO TRACTION-FLEXION CHAIR

Applicant Jilco Enterprises

K number K001361

View details →

ITH 2000-07-17

SPINAL CORD AND IMMOBILIZATION TRACTION SYSTEM

Applicant Cavendish Scott, Inc.

K number K001296

View details →

ITH 2000-07-12

AMT THERAPEUTIC TABLE, MODEL 748AMT

Applicant Amt Mfg., Inc.

K number K001401

View details →

ITH 2000-01-03

DYNATRON 900

Applicant Dynatronics Corp.

K number K993919

View details →

ITH 1999-12-20

HANG UPS POWER II

Applicant Stl Intl., Inc.

K number K991835

View details →

ITH 1999-11-10

AKRON ATP9 TRACTION MACHINE

Applicant Huntleigh Technology, Inc.

K number K992733

View details →

ITH 1999-09-01

TM-300 TRACTION SYSTEM

Applicant Ito Co., Ltd.

K number K992545

View details →

ITH 1999-08-12

CTD MARK I TRACTION DEVICE

Applicant Therasys, Inc.

K number K991931

View details →

ITH 1998-06-24

DRS SYSTEM

Applicant Professional Distribution Systems, Inc.

K number K981822

View details →

ITH 1996-07-02

VAX-D THERAPEUTIC TABLE

Applicant Vat-Tech, Inc.

K number K951622

View details →

ITH 1995-05-26

ATT-300

Applicant Health Care Mfg., Inc.

K number K944699

View details →

ITH 1995-05-17

ASH-7000

Applicant U.S. Table, Inc.

K number K951228

View details →

ITH 1994-06-07

EXCEL TX

Applicant Excel Tech. , Ltd.

K number K940200

View details →

ITH 1994-04-15

MINTO SKIN TRACTION MOTOR

Applicant Minto Research & Development, Inc.

K number K940590

View details →

ITH 1993-07-22

ACCUTRAC TRACTION UNIT

Applicant I-Rep, Inc.

K number K930691

View details →

ITH 1992-11-09

JT-1 POWERED TRACTION UNIT

Applicant Chirotronics, Inc.

K number K923103

View details →

ITH 1990-05-29

ULTRA-TRAC

Applicant Practical Healthcare Devices, Inc.

K number K900575

View details →

ITH 1990-05-24

DISTRAC(TM) TABLE

Applicant Lossing Orthopedic, Inc.

K number K900475

View details →

ITH 1989-08-03

VAX-T PELVIC TRACTION BELT

Applicant Vat-Tech, Inc.

K number K894435

View details →

ITH 1989-06-09

TRU TRAC TRACTION TABLE

Applicant Tru-Trac

K number K893448

View details →

ITH 1989-05-26

SPINALATOR JS-1100 TRACTION UNIT

Applicant The Spinalator Co.

K number K893168

View details →

ITH 1988-05-04

ULTRA TRACTION

Applicant Component Equipment Mfg., Inc.

K number K881603

View details →

ITH 1987-10-06

GUS TRAC C-303

Applicant Gus Company, Inc.

K number K872780

View details →

ITH 1986-08-07

TEC VARI-TRAC II TRACTION UNIT

Applicant Therapeutic Equipment Corp.

K number K862846

View details →

ITH 1986-08-06

TRU-TRAC 3-DIMENSIONAL CERVICAL TRACTION-TD-9000

Applicant Tru-Trac

K number K862579

View details →

ITH 1986-06-27

RICH-MAR SPINA-MOBILIZOR

Applicant Rich-Mar Corp.

K number K861832

View details →

ITH 1986-02-06

POWERED TRACTION EQUIPMENT

Applicant R. P. Hood, Inc.

K number K860227

View details →

ITH 1985-05-01

ESCOTEK EST TRAC 401

Applicant Nor-Am Patient Care Products, Inc.

K number K844385

View details →

ITH 1985-02-07

DONWAY SPLINT

Applicant Australian Biomedical Corporation , Ltd.

K number K843522

View details →

ITH 1984-12-11

PROM NAID

Applicant Lossing Orthopedic, Inc.

K number K843581

View details →

ITH 1984-01-13

TEC TRACTION MACHINE

Applicant Akron Medical Corp.

K number K834405

View details →

ITH 1983-01-24

TRACTION 230

Applicant Tri W-G, Inc.

K number K830088

View details →

ITH 1982-06-22

INVERCHAIR

Applicant Inverchair Marketing, Inc.

K number K821002

View details →

ITH 1977-11-30

CERVICAL TRACTION DIV., PNEUMATIC

Applicant Jobst

K number K772154

View details →

ITH 1977-04-08

TABLE, TREATMENT & TRACTION, HI-LO

Applicant Will Ross Co.

K number K770610

View details →