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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 K231780
Device Name Perifit Care+
Applicant
X6 Innovations
128 Rue De La Boétie
Paris,  FR 75008
Applicant Contact Robin Reynaud
Correspondent
Hogan Lovells US LLP
555 13th St., NW
Washington,  DC  20004
Correspondent Contact Lina Kontos
Regulation Number884.1425
Classification Product Code
HIR  
Date Received06/16/2023
Decision Date 12/20/2023
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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