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Last updated on April 24, 2014 at 21:24 EDT

Integrity Life Sciences Releases Corporate Resume

August 21, 2012

TAMPA, Fla., Aug. 21, 2012 /PRNewswire-iReach/ — Integrity Life Sciences continues to be recognized by the medical device industry for the exemplary history demonstrated by its team, its products and their history for patient satisfaction and safety. In response to several media and industry requests, Integrity Life Sciences has released its corporate resume highlighting the strength of its team. Team Integrity is guided by the leadership of James Gibson and has a cumulative 50 plus year track record in the health care industry with a specific demonstrated 15 year record of success in the global Non Surgical Spinal Decompression Industry. Below is a partial listing of the industry experience for Mr. Gibson and the companies he has led. The dedicated team at Integrity Life Sciences will continue to support legacy devices while pursuing continued medical innovations throughout the world.

(Photo: http://photos.prnewswire.com/prnh/20120821/CG60149)

Integrity Life Sciences, LLC

    Manufacturer and distributor of Integrity Spinal Care Systems
    2012                                                                                       CE           CE Mark 0197 TUV Rheinland LGA
                                                                                                             Products GMBH
    2012                                                                                       GS 1         Global Trade Item Number, UPC Barcode
    2012                                                                                       USA          US FDA, Certificate of Export to
                                                                                                             Foreign Governments
    2012                                                                                       US Patent    # 6152950 Apparatus for Therapeutic
                                                                                                             Treatment of Low Back Pain
    2012                                                                                       US Patent    # 7462189 Integrated Lumbar Combined
                                                                                                             Variable Angular Distraction
                                                                                                             Structure
    2012                                                                                       HIBCC        # M938 -Health Industry Bar Code
                                                                                                             (HIBC)
    2011                                                                                       FDA 510(k)   # 103248 Integrity Spinal Care System
    2012                                                                                       ISA          EN ISO 13485:2003 TUV Rheinland of
                                                                                                             North America

Axiom Worldwide, Inc., Axiom Worldwide, LLC, Axiom USA, Inc.

    Developer, Manufacturer and/or Distributors of the following:
     DRX2000, DRX3000, DRX5000, DRX9000, DRX9000C, DRX9500,
     PowerLaser, DTX4000, EPS8000, NVP8500
          2010        ISO                                 EN ISO 13485:2003 TUV Rheinland of
                                                          North America
          2010        CE                                  CE Mark 0197 TUV Rheinland LGA
                                                          Products GMBH
          2008        China                               Peoples Republic of China, State Food
                                                          and Drug Administration
          2008        Russia                              Federal Service of Healthcare and
                                                          Social Development Control
          2008        Japan                               Japanese Pharmaceutical Affairs Law
                                                          (PAL), TUV
          2007        Japan                               Japanese Pharmaceutical Affairs Law
                                                          (PAL), TUV
          2007        USA                                 USA FDA, Certificate of Export to
                                                          Foreign Governments
          2007        USA                                 Acquisition of Adagen Medical,
                                                          Distributor of the Accu-Spina (TM)
          2006        FDA 510(k)                          # 060735 DRX9000 true spinal
                                                          decompression
          2006        UL                                  UL 60601-1: 2003, r6.03, TUV
                                                          Rheinland North America
          2006        CAN/CSA                             CAN/CSA- c22.2 no. 601.1 - m90,
                                                          TUV Rheinland North America
          2006        USA                                 US FDA, Certificate of Export to
                                                          Foreign Governments
          2006        ISO                                 ENISO 13485:2003 TUV Rheinland
                                                          product safety GMBH
          2006        CE                                  CE Mark 0197 TUV Rheinland product
                                                          safety GMBH
          2006        Russia                              Federal Service of Healthcare and
                                                          Social Development Control
          2005        FDA 510(k)                         # 050687 Axiom EPS 8000
          2005        FDA 510(k)                         # 051135 Axiom NVP8500
          2005        FDA 510(k)                         # 050687 Axiom EPS 8000
          2005        UL                                  UL 60601-1:2003, r6.03, TUV
                                                          Rheinland North America
          2005        CAN/CSA                             CAN/CSA -c22.2 no. 601.1-m90, TUV
                                                          Rheinland North America
          2005        Korea                               KFDA, Korea food and drug
                                                          administration, pre-market process
          2005        USA                                 US FDA, certificate of export to
                                                          foreign governments
          2005        Canada                              Canadian Medical Devices Conformity
                                                          Assessment System (CMDCAS)
          2004        USA                                 US FDA, Certificate of Export to
                                                          Foreign Governments
          2004        ISO                                 EN 13485: 2003 TUV Rheinland product
                                                          safety GMBH
          2004        CE                                  CE Mark 0197 TUV Rheinland LGA
                                                          products GMBH
          2003        FDA 510(k)                         # 022602 DRX 3000
          2003        FDA 510(k)                          # 030622 Axiom Bio-Laser LLLT (Low
                                                          Level Light Therapy) series-1
          2003        FDA 510(k)                          # 033015 Axiom Bio-Laser LLLT (Low
                                                          Level Light Therapy) series-3
          2003        ISO                                 ISO 9001:2000, QMI, A division of CSA
                                                          Group
          2003        ISO                                 ISO 13488:1996, QMI, A division of
                                                          CSA Group
          2003        Canada                             Medical Device License, Class 2
          2002        FDA 510(k)                         # 023160 DRX5000
          2001        FDA 510(k)                         # 010292 DRX2000

Cluster Technology Corp. – Developer, Manufacturer and Distributor of: the DRS system

                2000 SEC       United States, Securities and
                               Exchange Commission, 10sb12g
                1999 CE        Mark CE, Intertrek Testing Services
                1998 Canada    Canadian Ministry of Health, Food
                               and Drugs Act, Medical Devices
                               Program
                1998 US Patent # 6152950 Apparatus for Therapeutic
                               Treatment of Low Back Pain
    1996 - 2000                  US FDA GMP (Good Manufacturing
                               Practice)

Integrity Life Sciences delivers a multitude of orthotic treatment options to address one of the most costly systemic ailments in the world, chronic low back and neck pain. The advanced solution begins with the Integrity Spinal Care System (ISCS 2.0) and The Lombare System. Both medical devices are non-surgical spinal decompression therapy systems engineered to provide pain relief for compressive and degenerative conditions of the spine. Specifically, conditions that may be treated include: neck pain and back pain associated with herniated discs, protruding discs, degenerative disc disease, posterior facet syndrome, and sciatica. It achieves these effects through decompression of intervertebral discs, that is, unloading due to distraction and positioning.

Integrity Life Sciences manufactures it products with quality and safety standards demonstrated by its ISO 13485 registered quality system with TUV SUD and the CE Mark affixed to its product. Our FDA clearance together with compliance to global harmonized standards of both Mark CE and ISO 13485 allows Integrity Life Sciences to distribute to countries all over the world. As the owner of multiple US Patents, Integrity Life Sciences is committed to ongoing research and development in support of the worldwide healthcare community. Integrity Life Sciences is a privately held USA based company with international partners located across the globe with a mission of “Restoring Integrity to the Spine”. For additional information please visit: www.IntegrityLifeSciences.com. To schedule an interview please contact: James Gibson, President & CEO at: telephone: 001-813-935-5500 or email: James@IntegrityLifeSciences.com.

Media Contact: James Gibson Integrity Life Sciences, LLC, 813-935-5500, james@integritylifesciences.com

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SOURCE Integrity Life Sciences, LLC


Source: PR Newswire