Disciplinary Warning Letter
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.+ k St +2/’ff WCC, + DEPARTMENT OF HEALTH HUW SERVItES “ - Public Health Service : z D1346 + ‘+ ,fj CERTIFIED MAIL RETURN RECEIPT Food and Drug Administration 7200 Lake Ellenor Drive Orlando, FL 32809 REQUESTED WARNING LETTER FLA-98-23 January Mr. David Williams Manager Professional Distribution Systems, 1160 South Rogers Circle Building A Boca Raton, Florida 33487 Dear Mr. 23, 1998 Inc.. The “DRS System” consists of the following components: (1) A TruTrac 401 Traction Unit, manufactured by Henley Healthcare, Sugar Land, Texas, which PDS calls the Vertrac Unit (2) the Omni Tower, manufactured by PDS, which is a vertical column that houses and controls the traction unit (via the Main Control Panel) , and to which is attached a Patient Light Bar and (3) a Powered (patient) Table manufactured by PDS.. Failure to document when a complaint requires further investigation and/or is reportable as a complaint or under the Medical Device Reporting (MDR) system, to document corrective actions taken, and to document replies to complainants in the record of the investigation, notes documenting contacts e“9”l concerning erro”r messages received from users that their devices failed after installation (serial nos.. arthropathy stenosis arthropathy surgical - in the may first week quickly if caused by can be treated resolve herniation, flow which with a “popll degeneration, through the spinal decreases nerve of nerve, diameter pain laminectomies can be treated after 6 months and, elevation for L5, 20 for L4 had previous surgery or long benefit from starting between Regardless of the merits of your claim that Henley Healthcare ac ired the rights to 510(k)K844385, the above 29 additional intended uses that the “DRS System” is labeled for are not covered by this 510(k)..
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