Product Classification

• Device: dielectric heaters, induction heaters, rf sealers
• Definition: A machine that utilizes industrial radiofrequency (rf) induction heating with rf fields in frequency range from 2-500 mhz for industrial heating.
• Product Code: RDA
• Device Class: Not Classified
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: Yes

    Note: This device is also exempted from the GMP regulation, except for general requirements concerning records (820.180) and complaint files (820.198), as long as the device is not labeled or otherwise represented as sterile.

• Summary Malfunction Reporting: Ineligible

Third Party Review

Not Third Party Eligible