Integrity Life Sciences Releases Corporate Resume
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.
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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
