Skip to content

Sport-Elec Duo CT5 Slimness

by Sport-Elec S.A.

510(k) K061914

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 NumberK061914 Date26 Jul 2007ClearedStatusActive

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  • Withdrawn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)

Full name
Sport-Elec, Models Duo CT5 Slimness and CT5 Slimness
510(k) Number
FDA Product Code
NGX
Device Class
Class II
Regulation
21 CFR Part 890.5850
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 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 Sport-Elec Duo CT5 Slimness is a powered muscle stimulator designed for muscle conditioning. It delivers trans‑cutaneous electrical muscle stimulation (EMS) through skin‑contact electrodes to activate muscle groups in healthy individuals.

The device is marketed by Sport‑Elec S.A. and has received FDA 510(k) clearance (K061914) under product code NGX as a Class II medical device. It is supplied as a complete system for use in physical medicine settings, with no specific sterility or single‑use claims provided in the available data.

Other devices from Sport-Elec

Questions

AI-generated answers, 21 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 intended use of the Sport-Elec Duo CT5 Slimness?

    It is designed to deliver trans‑cutaneous electrical muscle stimulation (EMS) to activate muscle groups for conditioning in healthy individuals, typically used in physical medicine settings.

  • How is the Duo CT5 Slimness supplied to users?

    The device is provided as a complete system, including the powered stimulator unit and skin‑contact electrodes, ready for immediate use without additional accessories.

  • Is the Duo CT5 Slimness a sterile or single‑use product?

    The available data do not specify sterility or single‑use status, indicating it is supplied as a reusable system without explicit sterile labeling.

  • What regulatory pathway did the Duo CT5 Slimness follow?

    It received FDA 510(k) clearance (K061914) under product code NGX, classified as a Class II medical device, and was found substantially equivalent to a predicate device.