Opgevolgd door ANODYNE

Zoals valt te lezen uit de FDA-registratie:

http://www.accessdata.fda.gov/cdrh_docs/pdf6/K062635.pdf
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications
for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).

is het apparaat afgeleid van, en in feite niet verschillend van warmtelampen die al vóór 1976 bekend waren
Daarmee is de inzetbaarheid van het apparaat duidelijk.