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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Perineometer
510(k) Number K240805
Device Name Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)
Applicant
Pelvital USA, Inc.
860 Blue Gentian Rd., Suite 200
Eagan,  MN  55121
Applicant Contact Lydia Zeller
Correspondent
RQM+
2790 Mosside Blvd.
#800
Monroeville,  PA  15146
Correspondent Contact Ming Cheng Chew
Regulation Number884.1425
Classification Product Code
HIR  
Date Received03/25/2024
Decision Date 08/01/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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