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U.S. Department of Health and Human Services

Product Classification

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Device massager, therapeutic, to internally massage trigger points in the pelvic floor musculature
Definition Rectal or vaginal use manual therapeutic massager device to massage irritable, sore trigger points (trps) in the pelvic floor musculature in order to reduce internal pelvic floor trigger point sensitivity.
Physical State An extended shaft witha hook-shaped end and a handle and a gauge that measures pressure of massage
Technical Method Manual massage
Target Area Pelvic floor musculature
Regulation Medical Specialty Physical Medicine
Review Panel Physical Medicine
Product CodeOSD
Premarket Review Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Physical Medicine and Rehabilitation Devices Branch (PMDB)
Submission Type 510(K) Exempt
Regulation Number 890.5670
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 now exempt from the premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (the Modernization 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 a requirement of the Modernization Act.
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible