Product Code: RDA FDA not classified

Dielectric Heaters, Induction Heaters, Rf Sealers

Unknown

The Dielectric Heaters, Induction Heaters, RF Sealers (product code RDA) are machines that utilize industrial radiofrequency induction heating with RF fields in the frequency range from 2 to 500 MHz for industrial heating applications. This product is FDA not classified and is regulated under electronic product radiation control authority rather than standard medical device classification. It is GMP exempt with no associated regulation number, medical specialty, implant flag, or life-sustaining designation.

510(k)s
0
FEI Numbers
0
Registration Numbers
0
Unique Applicants
0
Years Active

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Basic Information

Product Code
RDA
Device Class
FDA not classified
Medical Specialty
Unknown

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

Definition

A machine that utilizes industrial radiofrequency (rf) induction heating with rf fields in frequency range from 2-500 mhz for industrial heating.