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510(k) Data Aggregation
K Number
K092731Device Name
VIBRO-TRAC
Manufacturer
Date Cleared
2010-06-10
(279 days)
Product Code
Regulation Number
890.5880Why did this record match?
Applicant Name (Manufacturer) :
PNEUMEX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Vibro-Trac™ is a multi-function physical therapy table intended for medical purposes that consists of a motorized table which can be equipped to provide patients with powered distraction and muscle relaxation therapy.
Device Description
The Pneumex Vibro-Trac™ is a Hi-Lo multifunction distraction/vibration table designed to apply spinal muscle relaxation through vibration. The patient lies in a supine position on the table with the knees bent and supported at a 90° angle (e.g., supported by an exercise ball). The patient wears an upper body harness, which is attached by shoulder straps and carabineers to the head traction bars at a location to provide greater or less tension, as determined by the medical practitioner. The patient wears a pelvic belt with two tensioning straps attached to either side. The tensioning straps are adjusted to provide the required amount of tension, as determined by the medical practitioner.
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