2014

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

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 ™

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



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