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.
(Photo: http://photos.prnewswire.com/prnh/20120821/CG60149)
Integrity Life Sciences, LLC
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Manufacturer and distributor of Integrity Spinal Care Systems |
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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 | ||
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2012 |
US Patent |
# 7462189 Integrated Lumbar Combined Variable Angular Distraction Structure | ||
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2012 |
HIBCC |
# M938 - Health Industry Bar Code (HIBC) | ||
|
2011 |
FDA 510(k) |
# 103248 Integrity Spinal Care System | ||
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2012 |
ISA |
EN ISO 13485:2003 TUV Rheinland of North America | ||
Axiom Worldwide, Inc., Axiom Worldwide, LLC, Axiom USA, Inc.
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Developer, Manufacturer and/or Distributors of the following: DRX2000, DRX3000, DRX5000, DRX9000, DRX9000C, DRX9500, PowerLaser, DTX4000, EPS8000, NVP8500 | ||
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2010 |
ISO |
EN ISO 13485:2003 TUV Rheinland of North America |
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2010 |
CE |
CE Mark 0197 TUV Rheinland LGA Products GMBH |
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2008 |
China |
Peoples Republic of China, State Food and Drug Administration |
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2008 |
Russia |
Federal Service of Healthcare and Social Development Control |
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2008 |
Japan |
Japanese Pharmaceutical Affairs Law (PAL), TUV |
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2007 |
Japan |
Japanese Pharmaceutical Affairs Law (PAL), TUV |
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2007 |
USA |
USA FDA, Certificate of Export to Foreign Governments |
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2007 |
USA |
Acquisition of Adagen Medical, Distributor of the Accu-Spina ™ |
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2006 |
FDA 510(k) |
# 060735 DRX9000 true spinal decompression |
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2006 |
UL |
UL 60601-1: 2003, r6.03, TUV Rheinland North America |
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2006 |
CAN/CSA |
CAN/CSA- c22.2 no. 601.1 - m90, TUV Rheinland North America |
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2006 |
USA |
US FDA, Certificate of Export to Foreign Governments |
|
2006 |
ISO |
ENISO 13485:2003 TUV Rheinland product safety GMBH |
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2006 |
CE |
CE Mark 0197 TUV Rheinland product safety GMBH |
|
2006 |
Russia |
Federal Service of Healthcare and Social Development Control |
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2005 |
FDA 510(k) |
# 050687 Axiom EPS 8000 |
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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 |
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2005 |
CAN/CSA |
CAN/CSA - c22.2 no. 601.1- m90, TUV Rheinland North America |
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2005 |
Korea |
KFDA, Korea food and drug administration, pre-market process |
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2005 |
USA |
US FDA, certificate of export to foreign governments |
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2005 |
Canada |
Canadian Medical Devices Conformity Assessment System (CMDCAS) |
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2004 |
USA |
US FDA, Certificate of Export to Foreign Governments |
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2004 |
ISO |
EN 13485: 2003 TUV Rheinland product safety GMBH |
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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 |
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2003 |
ISO |
ISO 9001:2000, QMI, A division of CSA Group |
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2003 |
ISO |
ISO 13488:1996, QMI, A division of CSA Group |
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2003 |
Canada |
Medical Device License, Class 2 |
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2002 |
FDA 510(k) |
# 023160 DRX5000 |
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2001 |
FDA 510(k) |
# 010292 DRX2000 |
Cluster Technology Corp. – Developer, Manufacturer and Distributor of: the DRS system
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2000 |
SEC |
United States, Securities and Exchange Commission, 10sb12g |
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1999 |
CE |
Mark CE, Intertrek Testing Services |
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1998 |
Canada |
Canadian Ministry of Health, Food and Drugs Act, Medical Devices Program |
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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
RELATED LINKS
http://www.integritylifesciences.com
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