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HIR — Perineometer Class II

FDA Device Classification

Classification Details

Product Code
HIR
Device Class
Class II
Regulation Number
884.1425
Submission Type
Review Panel
GU
Medical Specialty
Obstetrics/Gynecology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K240805pelvital usaFlyte Mechanotherapy System, MTI-1.5 (MTI-1.5)August 1, 2024
K231875advanced tactile imagingVaginal Tactile Ultrasound ImagerFebruary 22, 2024
K233362pelvital usaFlyte Mechanotherapy System (aka Flyte System) (MTI-1.0)December 29, 2023
K231780x6 innovationsPerifit Care+December 20, 2023
K221476x6 innovationsPerifitFebruary 10, 2023
K213913renovialeva Pelvic Health SystemJune 30, 2022
K212655pelvital usaFlyteSeptember 21, 2021
K212495renoviaLeva Pelvic Health SystemSeptember 8, 2021
K210764pelvital usaFlyteApril 13, 2021
K193364plus ev holdings dba intimate roseIntimate Rose Kegel Exercise SystemAugust 24, 2020
K200409pelvital usaPelvital SystemJuly 10, 2020
K192270renoviaLEva Pelvic Digital Health SystemNovember 22, 2019
K180637renovialeva Pelvic Floor TrainerApril 4, 2018
K171896ralston groupFeminine Personal Trainer (FPT)August 29, 2017
K162689bioinfinity (m) sdn. bhdVibrance Pelvic TrainerJune 8, 2017
K160758analyticaPeriCoach OTCJuly 11, 2016
K142355advanced tactile imagingVaginal Tactile ImagerMay 28, 2015
K143580analyticaPeriCoachMarch 18, 2015
K141893bioinfinity (m) sdn. bhdVIBRANCE KEGEL DEVICE (VKD)December 18, 2014
K133990remendium labsIEVA REHABILITATIVE POSITIONAL DEVICEOctober 9, 2014