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InTone

by Incontrol Medical, LLC

510(k) K150180

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK150180 Date16 Mar 2015ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
KPI
Device class
Class II
Regulation
21 CFR Part 876.5320
Advisory committee
Gastroenterology, Urology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

Similar devices

Other devices filed under FDA product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence).

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