Ali097lil_312968158.jpg 💯 Genuine

: These monitors fall under the Urology category and are reviewed by the FDA's Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices.

While "ali097" and the subsequent numerical string ("312968158") are likely internal database identifiers or patient/lot numbers, the inclusion of is a standard practice in medical imaging and regulatory documentation to quickly identify the device type. Summary of Regulatory Classification Information Product Code LIL Device Name Monitor, Penile Tumescence FDA Review Panel Device Class Submission Type LIL - Product Classification - FDA ali097LIL_312968158.jpg

: This is a Class II medical device, which requires "general and special controls" to ensure safety and effectiveness. : These monitors fall under the Urology category

Devices classified under the product code are used in medical settings to assess and record erectile function, typically to help clinicians distinguish between physiological and psychological causes of impotence. Devices classified under the product code are used