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U.S. Department of Health and Human Services

Product Classification
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Device electrical tumor treatment fields
Definition The device is intended to treat patients with inoperable malignant pleural mesothelioma (MPM) concurrent to chemotherapy.
Physical State The device consists of sets of contact electrodes that are applied to the patient's shaved chest, a connecting cable, battery pack and signal generator.
Technical Method This is a portable, battery powered device. Electric fields are continuously applied to the target chest area for a pre-specified duration of time.
Target Area Chest/upper torso
Review Panel Anesthesiology
Product CodeQGZ
Premarket Review Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Submission Type HDE - Humanitarian Device Exemption
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? Yes
Third Party Review Not Third Party Eligible
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