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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature
510(k) Number K250419
Device Name Intimate Rose Pelvic Wand (Purple); Intimate Rose Bendable Pelvic Wand (Orange); Intimate Rose Temperature Pelvic Wand (Yellow)
Applicant
Plus EV Holdings, Inc. D/B/A Intimate Rose
1419 Murray St.
North Kansas City,  MO  64116
Applicant Contact Aaron Wilt
Correspondent
Medical Device Academy, Inc.
345 Lincoln Hill Rd.
Shrewsbury,  VT  05738
Correspondent Contact Rob Packard
Regulation Number890.5670
Classification Product Code
OSD  
Date Received02/13/2025
Decision Date 07/27/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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