Extaciser Perineal Muscle Exerciser

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K892888 ↗

FDA Product Code

HIR

Device Class

Class II

Regulation

21 CFR Part 884.1425

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

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See all devices from Bivona Medical Technologies →

• What types of pelvic floor muscles can the Extaciser Perineal Muscle Exerciser assess, and how does it provide feedback for therapy?

  The Extaciser Perineal Muscle Exerciser measures the strength and endurance of pelvic floor muscles, specifically including the vaginal and perineal musculature. It provides quantitative data that aids in assessing pelvic floor disorders and supports biofeedback therapy by offering measurable results to guide patient exercises and rehabilitation.

• Is the Extaciser Perineal Muscle Exerciser intended for single-use or reusable applications, and how should it be stored?

  The device specifications do not explicitly state single-use or reusable status, but as a diagnostic perineometer cleared for clinical use, it is typically designed for repeated use in a clinical setting. Proper storage instructions are not provided in the data, but generally, such devices should be stored in a clean, dry environment away from direct sunlight and extreme temperatures to maintain accuracy and hygiene.

• What regulatory pathway was followed for FDA clearance of the Extaciser Perineal Muscle Exerciser, and what does this mean for its use?

  The Extaciser Perineal Muscle Exerciser was cleared through a traditional FDA 510(k) submission (K892888) as a Class II device under product code HIR, with a determination of substantial equivalence to a predicate device. This means the device was evaluated for safety and effectiveness based on comparisons to existing technology and was cleared for use in clinical settings for measuring pelvic floor muscle strength and endurance.

• Are there multiple models or sizes available for the Extaciser Perineal Muscle Exerciser, and how would I identify the correct one for my needs?

  The data lists multiple registration numbers (e.g., 3006636961, 3013426279, etc.), which may correspond to different models or variations of the Extaciser Perineal Muscle Exerciser. While the exact specifications for each model are not detailed, these identifiers can be used to verify compatibility with your clinical needs. Contacting Bivona Medical Technologies directly would be the best way to confirm which model aligns with your requirements.