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U.S. Department of Health and Human Services

Product Classification

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Device vibrator for climax control of premature ejaculation
Regulation Description Vibrator for climax control of premature ejaculation.
Definition Vibrator for climax control training for the treatment of premature ejaculation.
Physical State The device consists of a vibrator connected to a battery pack.
Technical Method Battery-operated vibrator and lubricant for climax control of premature ejaculation for men
Target Area Male genitals
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodePIA
Premarket Review Office of Device Evaluation (ODE)
Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD)
Urology and Lithotripsy Devices Branch (ULDB)
Submission Type 510(K) Exempt
Regulation Number 876.5025
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
    Note: Class II devices the Food and Drug Administration (FDA) has also published a list of class II (special controls) devices subject to certain limitations, that are exempt from premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (FDAMA) and the 21st Century Cures Act of 2016 (Cures Act). FDA believes that these exemptions will relieve manufacturers from the need to submit premarket notification submissions for these devices and will enable FDA to redirect the resources that would be spent on reviewing such submissions to more significant public health issues. FDA is taking this action in order to meet requirements of FDAMA and the Cures Act.
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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