 Patient Advocate (old timer, 2000 posts)
Joined: Nov 2002 Posts: 3,552 | Here's a link to the FDA clearance to market for it - unfortunately they didn't file a 510(k) "summary statment of safety and effectiveness" so there isn't much information (other than the brief "indications for use" statement). There are links to the manufacturer. It was cleared to market in Dec. 2002 and was found to be "substantially equivalent" to existing devices on the market at that time. It is similar to a TENS unit. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=9690
Gary Allsebrook
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Dx 11/22/02, SCC, 6 x 3 cm Polypoid tumor, rt tonsil, Stage III/IVA, T3N0M0 G1/2
Tx 1/28/03 - 3/19/03, Cisplatin ct x2, IMRT, bilateral, with boost, x35(69.96Gy)
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"You are a mist that appears for a little while and then vanishes" (James 4:14 NIV)
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