Skip to content

Feminine Personal Trainer (FPT)

by Ralston Group

510(k) K171896

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

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK171896 Date29 Aug 2017ClearedStatusActive

Recalls

0 recalls · FDA

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

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  • Withdrawn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
HIR
Device Class
Class II
Regulation
21 CFR Part 884.1425
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 Feminine Personal Trainer (FPT) is a perineometer indicated for the strengthening of the perineal pelvic floor muscles by providing resistance to an individual's voluntary contractions of these muscles. It is designed to correct urinary incontinence through exercise.

The device is supplied as a reusable instrument and received FDA 510(k) clearance under K171896 on 2017-08-29. It is classified as a Class II medical device with product code HIR and regulation number 884.1425, and is intended for use in obstetrics and gynecology settings.

Questions

AI-generated answers, 27 Sep 2026

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

  • What is the Feminine Personal Trainer (FPT) used for?

    The Feminine Personal Trainer (FPT) is indicated for the strengthening of the perineal pelvic floor muscles by providing resistance to voluntary contractions, and is designed to correct urinary incontinence through exercise.

  • How is the Feminine Personal Trainer (FPT) supplied and is it reusable?

    The Feminine Personal Trainer (FPT) is supplied as a reusable instrument, meaning it is intended for multiple uses after appropriate cleaning and disinfection between patients.

  • What regulatory pathway was used for the Feminine Personal Trainer (FPT) and when was it cleared?

    The Feminine Personal Trainer (FPT) received FDA 510(k) clearance under K171896 on 2017-08-29, following a traditional submission process and was found substantially equivalent to a predicate device.