Skip to content

Ts-700P Control Xp Electrical Stimulator

by Myo/Kinetic Systems, Inc.

510(k) K945292

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 NumberK945292 Date12 Apr 1995ClearedStatusActive

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  • Withdrawn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
KPI
Device Class
Class II
Regulation
21 CFR Part 876.5320
Advisory Committee
Gastroenterology, Urology
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.

This device is an electrical stimulator, non-implantable, for incontinence, as defined in the device name and openFDA data. It is a substantially equivalent device cleared under FDA 510(k) K945292.

It is supplied by Myo/Kinetic Systems, Inc., located in Menomonee Falls, WI, with FDA registration numbers and medical specialty classifications in gastroenterology and urology. The device is classified as class II and was cleared on April 12, 1995, under traditional 510(k) review.

Other devices from Myo/Kinetic Systems, Inc.

See all devices from Myo/Kinetic Systems, Inc. →

Questions

AI-generated answers, 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.

  • What is the TS-700P CONTROL XP Electrical Stimulator used for?

    The TS-700P CONTROL XP Electrical Stimulator is a non-implantable device designed for the treatment of incontinence, as specified in its device name and supported by its FDA 510(k) clearance under K945292 for this indication.

  • Who manufactures the TS-700P CONTROL XP Electrical Stimulator and where is it supplied from?

    The TS-700P CONTROL XP Electrical Stimulator is manufactured by Myo/Kinetic Systems, Inc., located at N84 W13562 Leon Rd., Menomonee Falls, WI 53051, United States, as indicated in the device’s registration and address data.

  • Is the TS-700P CONTROL XP Electrical Stimulator implantable or non-implantable?

    The TS-700P CONTROL XP Electrical Stimulator is explicitly defined as non-implantable in both the device name and the openFDA data, meaning it is intended for external use and not surgical implantation.

  • What regulatory pathway was used to clear the TS-700P CONTROL XP Electrical Stimulator?

    The TS-700P CONTROL XP Electrical Stimulator was cleared through the traditional FDA 510(k) process under submission K945292, with a decision date of April 12, 1995, confirming its substantial equivalence to a legally marketed predicate device.

  • What medical specialties are associated with the TS-700P CONTROL XP Electrical Stimulator?

    The device is classified under the medical specialties of gastroenterology and urology, as reflected in the openFDA medical_specialty_description field and the review_advisory_committee designation of 'GU'.