Kegel Smart KegelSmart Pearl

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K140780 ↗

FDA Product Code

HIR

Device Class

Class II

Regulation

21 CFR Part 884.1425

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Sl 803, Sl 804, Sl 807, Sl 809, Sl 506, Sl 501, Sl 805 and Sl 801 Mechanical Wheelchairs

  Class I

  FDA 510(k) K020100 Active Cleared 8 Mar 2002

• Etherea

  Class II

  FDA 510(k) K112505 Active Cleared 6 Apr 2012

• En 600-658, En 600-666, En 600-664, En 600-690, En 600-651, En 600-663, En 600-665 and En 600-670 Mechanical Wheelchairs

  Class I

  FDA 510(k) K020094 Active Cleared 8 Mar 2002

• What is the KegelSmart Pearl used for?

  The KegelSmart Pearl is a perineometer designed to measure the strength of pelvic floor muscles. It assists clinicians in evaluating and monitoring pelvic floor muscle dysfunction, which can occur due to pregnancy, childbirth, or other conditions affecting pelvic floor health. By providing quantitative measurements, it helps tailor treatment plans for pelvic floor rehabilitation.

• Is the KegelSmart Pearl single-use or reusable?

  The KegelSmart Pearl is supplied as a single-use device. This design ensures hygiene and reduces the risk of cross-contamination between patients, which is particularly important in clinical settings where multiple patients may be assessed. Single-use devices also eliminate the need for sterilization between uses, simplifying workflow and ensuring consistent performance.

• Can the KegelSmart Pearl be used in an MRI environment?

  No, the KegelSmart Pearl is not MRI compatible. If MRI scans are required for a patient, the device should not be used during the assessment or treatment session. Clinicians should ensure the device is removed from the patient and stored safely away from MRI equipment to avoid interference or damage to either the device or the imaging system.

• What regulatory approval does the KegelSmart Pearl hold?

  The KegelSmart Pearl holds FDA 510(k) clearance, classified as a Class II medical device under product code HIR and regulation number 884.1425. This classification indicates it is intended for use in obstetrics/gynecology and has been determined to be substantially equivalent to a legally marketed predicate device. The clearance ensures it meets applicable safety and performance standards for its intended use.

• Are there different sizes or models of the KegelSmart Pearl?

  The provided data does not specify multiple sizes or models for the KegelSmart Pearl, indicating it is likely offered as a single standardized device. However, the device is designed to accommodate varying pelvic floor muscle strengths through its measurement capabilities. If specific sizing options are required for certain patient populations, clinicians should confirm compatibility with the manufacturer before use.