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The Triton/Tru-Trac/TX traction devices provide traction and mobilization of skeletal structures and skeletal muscles.

The Triton/Tru-Trac/TX traction devices provide a treatment in static, intermittent, progressive, regressive and cycling distraction forces to relieve pressures on structures that may be causing pain of skeletal or muscular origin (cervical, thoracic, lumbar, hip, knee, ankle, wrist, shoulder). Distraction can be applied in a variety of programmable patterns, cycles and functions.

The Triton/Tru-Trac/TX traction devices may be used to relieve peripheral radiation/sciatica and pain associated with:

• Protruding discs

• Bulging discs

• Herniated discs

• Degenerative disc disease

• Posterior facet syndrome

• Acute facet problems

• Radicular pain

• Prolapsed discs

• Spinal root impingement

• Hypomobility

• Degenerative joint disease

• Facet syndrome

• Compressions fractures

• Joint pain

• Discogenic pain

The Triton/Tru-Trac/TX traction devices achieve these effects through decompression of intervertebral discs, that is, unloading due to distraction and positioning.

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This document is a 510(k) premarket notification letter from the FDA regarding a traction device. It does not contain any information about acceptance criteria or a study proving device performance.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.

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