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U.S. Department of Health and Human Services

Product Classification

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Device hemorrhoid prevention pressure wedge
Regulation Description Hemorrhoid prevention pressure wedge.
Definition Provides a counter-pressure to the anus during vaginal delivery.Intended to prevent the occurrence of and/or stop the progression of hemorrhoids associated with vaginal delivery.
Physical State Items include: rigid base with cushioning pad and two lateral straps and two adhesive pads that are applied to the buttocks
Technical Method Uses a rigid base with cushioning pad applied to the anus held in place by two adhesive strips attached to the buttocks, to provide a counter-pressure to the anus during vaginal delivery
Target Area anus, hemorrhoids
Regulation Medical Specialty Obstetrics/Gynecology
Review Panel Obstetrics/Gynecology
Product CodeOOA
Premarket Review Office of Device Evaluation (ODE)
Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD)
Obstetrics and Gynecology Devices Branch (OGDB)
Submission Type 510(K) Exempt
Regulation Number 884.5200
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible