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Health / Pain / Medical equipment / Spinal decompression / Sciatica / Spinal disc herniation / Low back pain / Degenerative disc disease / Back pain / Medicine / Vertebral column / Anatomy


:INTEGRTYf FEB[removed]LIFE SCIENCES K130249
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Document Date: 2014-03-07 12:04:47

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File Size: 191,42 KB

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City

Tampa / /

Company

Code DRX9000 True Non Surgical Decompression Axiom Worldwide LLC / /

Event

FDA Phase / /

Facility

Drug Administration Document Control Center / /

/

IndustryTerm

traction equipment / announcements concerning your device / predicate devices / manufacturing shte / predicate device / manufacturing practice requirements / risk management / marketed predicate devices / manufacturing practice / /

MedicalCondition

degenerative disc disease / herniated discs / sciatica / posterior facet syndrome / pain / compressive and degenerative injuries / low back pain / /

MedicalTreatment

relaxation / /

Organization

Division of Postmarket Surveillance / HUMAN SERVICES Public Health Service / M.S. Director Division of Neurological / Food and Drug Administration / Center for Devices and Radiological Health / Device Evaluation Center for Devices and Radiological Health Enclosure Indications for Use / office of Surveillance / Neurological and Physical Medicine Devices Office / FDA / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / Drug Administration Document Control Center / /

Person

James J. Gibson / Jr. / Silver Spring / Carlos L. Pefia / James J. Gibson / /

/

Position

physician / ITH Applicant/Official / General / /

Product

Federal Food / 5I10 / /

ProgrammingLanguage

FL / /

ProvinceOrState

Maryland / Florida / /

Technology

radiation / /

URL

www.fda.gov/MedicalDevices / http /

SocialTag