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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
Regulation Description Internal therapeutic massager.
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 Neurological and Physical Medicine Devices (OHT5)
Neuromodulation and Rehabilitation Devices (DHT5B)
Submission Type 510(k)
Regulation Number 890.5670
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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