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InTone

FDA 510(k)

Class II (US FDA 510(k))

510(k) K150180

by Incontrol Medical, Llc

Identifiers

510(k) Number
K150180 FDA 510(k)
FDA Product Code
KPI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.5320 FDA 510(k)
Regulation Number
876.5320 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The InTone is a non-implantable electrical stimulator classified as a Stimulator, Electrical, Non-Implantable, For Incontinence. It delivers controlled electrical impulses to target muscles involved in urinary or fecal incontinence, helping to restore voluntary control and improve bladder function. Designed for both men and women, the device is intended for non-surgical treatment of stress, urge, or mixed incontinence without medication. Its mechanism relies on neuromuscular electrical stimulation to strengthen pelvic floor muscles and enhance continence.

The InTone is supplied as a reusable device and is intended for use in clinical or home settings under professional guidance. It operates with a KPI product code and falls under FDA regulation 876.5320, with a Traditional 510(k) clearance (K150180) granted in 2015. The device is not sterile and requires proper cleaning and maintenance between uses. No MRI safety information is specified, and its design does not include implantable components. Authorized for distribution in the United States, it adheres to Class II medical device standards for electrical stimulators.

Frequently asked questions

What types of incontinence does the InTone help manage, and how does it work to improve bladder control?

The InTone is designed to address stress, urge, or mixed urinary incontinence in both men and women. It uses neuromuscular electrical stimulation to target and strengthen pelvic floor muscles, helping restore voluntary control and improve bladder function without surgery or medication. The device delivers controlled electrical impulses to enhance muscle coordination and continence.

Is the InTone meant for home use, or is it primarily intended for clinical settings?

The InTone is intended for use in both clinical and home settings, but it requires professional guidance. Since it is a reusable device, it is typically supervised by a healthcare provider to ensure proper application, cleaning, and maintenance between uses.

How should the InTone be cleaned and maintained between uses, given it is not sterile?

Because the InTone is reusable and not sterile, it must be cleaned and maintained properly between uses to prevent contamination. The manufacturer provides specific cleaning instructions, which likely include disinfection protocols to ensure hygiene and safe reuse. Always follow the included guidelines to avoid damage or infection.

What are the key differences between the InTone and other non-implantable electrical stimulators for incontinence?

The InTone is specifically designed as a non-implantable, reusable device for neuromuscular electrical stimulation of pelvic floor muscles, targeting stress, urge, or mixed incontinence. Unlike implantable devices, it does not require surgical placement and is intended for non-surgical treatment. Its FDA clearance under product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence) distinguishes it from other stimulators, which may have different regulatory pathways or indications.

Are there any specific storage requirements for the InTone, and how should it be stored when not in use?

While the device data does not specify exact storage conditions, reusable medical devices like the InTone typically require protection from moisture, dust, and extreme temperatures. It should be stored in a clean, dry environment, away from direct sunlight or sources of heat. Always refer to the manufacturer’s instructions for precise storage guidelines to maintain device integrity and functionality.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: FDA Clearance Means InControl Medical has Both Ends Covered ... - Medlatest, InTone: Treatment for Urinary Incontinence without Medication or ..., InControl Medical InTone User Manual: AI Chat & PDF | Manualzz, InControl Medical Received FDA Clearance for Their Proprietary ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Incontrol Medical, Llc

Sources (1)

  • FDA 510(k) K150180 24 fields · synced Sep 20, 2026