Medical Equipment Designs 9-March-99 Diathermy devices
Since 1990, you also modified the design of the Meditherm
by introducing software to control the device. Major changes in the intended use of
the Meditherm and design changes which could significantly affect safety or
effectiveness, such as the introduction of software, require a new premarket
notification (510(k)) submission (Title 21, CFR, Part 807, Section 81(a)(3)).
Because you do not have marketing clearance from FDA for your current
Meditherm device, marketing your product is a violation of the law.
