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510(k) Data Aggregation
K Number
K060735Device Name
DRX9000 TRUE SPINAL DECOMPRESSION SYSTEM
Manufacturer
AXIOM WORLDWIDE, INC.
Date Cleared
2006-05-26
(67 days)
Product Code
ITH
Regulation Number
890.5900Why did this record match?
Applicant Name (Manufacturer) :
AXIOM WORLDWIDE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DRX9000 True Decompression System is designed to relieve pressure on structures that may be causing low back pain and sciatica. It relieves the pain associated with herniated discs, degenerative disc disease, posterior facet syndrome and radicular pain. Intervertebral disc decompression is achieved non-surgically through the application of logarithmic distraction tensions applied to the patient according to the Axiom protocol.
The DRX9000 True Non-Surgical Spinal Decompression System provides a primary treatment modality for the management of pain and disability for patients suffering with incapacitating low back pain and sciatica. It is designed to apply spinal decompressive forces to compressive and degenerative injuries of the spine. It has been found to provide relief of pain and symptoms associated with herniated discs, bulging or protruding intervertebral discs, degenerative disc disease, posterior facet syndrome and sciatica.
Device Description
The DRX9000 True Non-Surgical Spinal Decompression System provides accurately controlled tensions designed to relax and confuse paraspinal muscles and allow distractive forces to decompress intervertebral spinal disc space. The user interface provided by the treatment computer constantly updates a servo-amplifier controlling a servo-motor to immediately and safely apply forces as determined by qualified healthcare personnel. Load-cell feedback is utilized to further verify and adjust tensile forces, allowing for variations in patient posture and outside forces such that continuous and smooth tension is experienced by the patient. The patient safety switch is held by the patient who at anytime and for any reason may quickly pause any tensile forces. This patient safety switch is monitored and executed by two redundant systems. Integral to effective spinal decompression and included in the device are continuous load-cell tensile feedback into the treatment computer, dedicated and matched servo-amplifier and servo-motor, smoothly modulated cyclic tension application (high and low tension plateaus transitioned into via non-linear tension change), two segment (upper and lower) textile patient harness, patient safety switch, and free-floating lower body mattress. The free-floating lower body mattress allows the interdiscal segments of the lumbar spine to decompress at their own rate. As tension is cycled, the lower body can extend independent of the upper body which is held in place via an upper body textile patient harness. The treatment bed and textile harness allow the patient to relax completely and require no conscious exertion on the part of the patient. Total patient relaxation encourages paraspinal muscle relaxation from both a physical and psychological standpoint and is a key to spinal decompression.
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K Number
K051135Device Name
AXIOM NVP8500
Manufacturer
AXIOM WORLDWIDE, INC.
Date Cleared
2005-08-11
(100 days)
Product Code
IPF, GXY, LIH
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
AXIOM WORLDWIDE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Stimulate peripheral nerves for the purpose of providing pain relief and to stimulate motor nerves for the purpose of muscle rehabilitation.
PAIN MANAGEMENT
- For adjunctive treatment of post-traumatic pain syndromes .
- For management and symptomatic relief of chronic (long-term) intractable . pain and inflammation
- As an adjunctive treatment in the management of post-surgical pain . problems
MUSCLE STIMULATION
- Relaxation of Muscle Spasms .
- Prevention or Retardation of Tissue Atrophy .
- Increasing Local Blood Circulation ●
- Muscle Re-education
- Immediate Post-Surgical Stimulation of Calf Muscles to prevent venous ● thrombosis
- . Maintaining or increasing range of motion
Device Description
Not Found
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K Number
K050687Device Name
AXIOM EPS8000
Manufacturer
AXIOM WORLDWIDE, INC.
Date Cleared
2005-07-28
(133 days)
Product Code
IPF, GXY, LIH
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
AXIOM WORLDWIDE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Stimulate peripheral nerves for the purpose of providing pain relief and to stimulate motor nerves for the purpose of muscle rehabilitation.
PAIN MANAGEMENT
- For adjunctive treatment of post-traumatic pain syndromes .
- For management and symptomatic relief of chronic (long-term) intractable . pain and inflammation
- As an adjunctive treatment the management of post-surgical pain . problems
MUSCLE STIMULATION
- Relaxation of Muscle Spasms ●
- Prevention or Retardation of Tissue Atrophy .
- Increasing Local Blood Circulation ●
- Muscle Re-education ●
- Immediate Post-Surgical Stimulation of Calf Muscles to prevent venous . thrombosis
- Maintaining or increasing range of motion .
Device Description
Not Found
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K Number
K010292Device Name
DRX 2000
Manufacturer
AXIOM WORLDWIDE, INC.
Date Cleared
2001-05-01
(90 days)
Product Code
ITH
Regulation Number
890.5900Why did this record match?
Applicant Name (Manufacturer) :
AXIOM WORLDWIDE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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