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510(k) K212655

Device
Flyte
Applicant
Pelvital USA, Inc.
510(k) number
K212655
Product code
HIR
Decision
Substantially Equivalent (SESE)
Decision date
2021-09-21
Date received
2021-08-23
Regulation
884.1425
Classification name
Perineometer
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Special
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
Dale Wahlstrom
Address
1000 Lasalle Ave., Sch 435 Minneapolis MN US 55403 55403

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HIR#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252748Pelvic Floor Exerciser (PF01)Hunan Accurate Bio-Medical Technology Co., Ltd.2026-04-27
K240805Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)Pelvital USA, Inc.2024-08-01
K231875Vaginal Tactile Ultrasound ImagerAdvanced Tactile Imaging, Inc.2024-02-22
K233362Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)Pelvital USA, Inc.2023-12-29
K231780Perifit Care+X6 Innovations2023-12-20
K221476PerifitX6 Innovations2023-02-10
K213913leva Pelvic Health SystemRenovia, Inc.2022-06-30
K212495Leva Pelvic Health SystemRenovia, Inc.2021-09-08
K210764FlytePelvital USA, Inc.2021-04-13
K193364Intimate Rose Kegel Exercise SystemPlus EV Holdings Dba Intimate Rose2020-08-24
K200409Pelvital SystemPelvital USA, Inc.2020-07-10
K192270LEva Pelvic Digital Health SystemRenovia, Inc.2019-11-22
K180637leva Pelvic Floor TrainerRenovia, Inc.2018-04-04
K171896Feminine Personal Trainer (FPT)Ralston Group2017-08-29
K162689Vibrance Pelvic TrainerBioinfinity (M) Sdn. Bhd.2017-06-08