I can't say for sure but this is the classification of devices:
The FDA’s Classification System Divides Medical Devices into Three Classes:
• Class I: devices posing the lowest risk to patients or users
• Class II: devices that could harm patients or users if used improperly or malfunction
• Class III: devices that could severely injure or kill patients or users if used improperly or malfunction
Ann: Appendix 4E and 2018 Annual Report, page-6
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