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Incontrol Perineometer

by Thought Technology Ltd.

510(k) K935213

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 NumberK935213 Date11 May 1995ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

Full name
Incontrol
510(k) Number
FDA product code
HIR
FDA applicant
Thought Technology , Ltd.
Device class
Class II
Regulation
21 CFR Part 884.1425
Advisory committee
Obstetrics/Gynecology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Incontrol Perineometer is a medical device classified as a perineometer, designed to measure the strength and function of the perineal muscles. It provides quantitative assessment of pelvic floor muscle activity, which is critical for evaluating obstetric and gynecological conditions. This device aids clinicians in monitoring muscle tone, coordination, and recovery during pregnancy, childbirth, and postpartum rehabilitation. Its data-driven approach supports tailored treatment plans for pelvic floor dysfunction.

The Incontrol Perineometer is supplied as a reusable medical instrument and is intended for use in clinical settings such as obstetrics and gynecology departments. It operates under standard cleanliness protocols and is not classified as sterile. The device is MRI-unsafe and must be used in environments where MRI procedures are not conducted simultaneously. Multiple model variants are available, as indicated by the registration numbers, ensuring compatibility with various clinical workflows. Authorized under FDA 510(k) clearance (K935213), it adheres to regulatory standards for obstetric/gynecological devices.

Devices cleared under K935213

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K935213
UDI-DISize and differences
U-Control 60Hz Unit TT SA8825
Thought Technology Ltd.
SA882507540191000067 —On the market

Similar devices

Other devices filed under FDA product code HIR (Perineometer).

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