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510(k) Data Aggregation
K Number
K031227Device Name
LORDEX POWER TRACTION EQUIPMENT
Manufacturer
EVER PROSPEROUS INSTRUMENT INC
Date Cleared
2003-07-17
(90 days)
Product Code
ITH
Regulation Number
890.5900Why did this record match?
Applicant Name (Manufacturer) :
EVER PROSPEROUS INSTRUMENT INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Lordex Power Traction Unit provides a program of treatments for relief from pain for those patients suffering with low back pain. Each treatment consists of a physician prescribed treatment period on the Lordex Traction Unit, and is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back pain. It relieves 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.
Device Description
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