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510(k) Data Aggregation
K Number
K133990Device Name
IEVA REHABILITATIVE POSITIONAL DEVICE
Manufacturer
REMENDIUM LABS, LLC
Date Cleared
2014-10-09
(286 days)
Product Code
HIR
Regulation Number
884.1425Why did this record match?
Applicant Name (Manufacturer) :
REMENDIUM LABS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The leva Pelvic Floor Trainer is intended for the purpose of rehabilitation and training of weak pelvic floor muscles for the treatment of stress, mixed and mildmoderate urge incontinence in women. This device interacts with the user via smart phone technology.
Device Description
The leva Rehabilitative Positional Device is a device specifically designed to facilitate Kegel exercise training of women with urinary incontinence by physicians and associated therapists. The device is designed to be discreet and simple to use. Each leva is intended to be used repeatedly by a single patient. The device is designed to be used vaginally.
The RPD hardware consists of the training device itself and an associated battery powered electronics box. The training device has a biocompatible, colored silicone covering which isolates the motion electronics from the environment. The patient inserts the training device in her vagina before commencing Kegel exercises and wirelessly connect the RPD to the smartphone. The training device remains in place during the Kegel exercises. This device can be washed before and after exercise by the patient.
A smartphone, with the appropriate app, is used to connect wirelessly to the RPD and shows the angle of the pelvic floor and the relative motion. This enables the user to visualize the Keqel exercise she is being trained on. The app will carry the information recorded by the patient on her smartphone or tablet. Such information will then connect to a website for the patient or health care provider to store information and retrieve information related to the use of the RPD.
A website is provided for access by the patient, health care provider and insurance company. This website provides utilities for the patient, the health care provider and the insurance company. For the patient the website provides ongoinq tracking of performance—showing improvement in the patient's Keqel exercises when using the RPD. The health care provider shall have access for monitoring their patients' performance.
One RPD is intended for only one patient per device and there is no applicable shelf life for this device.
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