HTML Preview Disciplinary Warning Letter page number 1.
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DEPARTMENT OF HEALTH & HUW SERVItES “ -
Public Health Service
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Food and Drug Administration
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CERTIFIED MAIL
7200 Lake Ellenor Drive
RETURN RECEIPT REQUESTED
Orlando, FL 32809
WARNING LETTER
FLA-98-23
January 23, 1998
Mr. David Williams
Manager
Professional Distribution Systems, Inc.
1160 South Rogers Circle
Building A
Boca Raton, Florida
33487
Dear Mr.
Williams:
We are writing to you because on August 18 through 28,
1997,
Investigator
Michelle S. Dunaway from the Food
and
Drug
Administration (FDA) collected information that revealed a serious
regulatory problem involving the product known as the ‘IDRS SystemIl.
This product is manufactured, distributed, and promoted by your
firm,
Professional Distribution Systems, Inc. (hereafter PDS),
which is a subsidiary of Cluster Technology Corporation.
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.
The PDS Powered Table is integrated to
the Omni Tower via a laser light attached to the table which
illuminates a reference point on the Omni Tower,
which in turn
identifies the angle of pull of the Vertrac Unit.
The table is
also integrated to the Omni Tower/Vertrac Unit via the patient, who
is pulled by the Vertrac Unit while being secured to the table.
We understand that the “DRS System” could also include the optional
“Microlight 830 Cold Laser”,
also manufactured by Henley Healthcare
(previously Lasermedics,
Inc.) , which is an Investigational Device
being offered “on a limited basis under an approved IRB protocol
headed by C. Norman Shealy, M.D.”.
However, we understand that the
Microlight
830 is not
routinely
sold with the DRS
System;
therefore,
for the purposes of this discussion, we will consider
the Microlight 830 separately,
and our reference to the
“ DRS
System” hereafter in this letter excludes the Microlight 830 Cold
Laser.