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FLIX-EMS

by Casgarum Investment, S.L.

510(k) K181419

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 NumberK181419 Date14 May 2019ClearedStatusActive

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  • Withdrawn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
NGX
Device Class
Class II
Regulation
21 CFR Part 890.5850
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

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

FLIX-EMS is an electrotherapy device classified under Physical Medicine. It is substantially equivalent to a predicate device regarding safety and effectiveness.

The device is supplied by Casgarum Investment, S.L. and has FDA 510(k) clearance with product code NGX. No information regarding sterility, single-use or reusable status, MRI safety, or sizes is provided.

Questions

AI-generated answers, 25 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 FLIX-EMS used for?

    FLIX-EMS is an electrotherapy device classified under Physical Medicine, designed for therapeutic applications. It has been determined to be substantially equivalent to a predicate device regarding safety and effectiveness.

  • What is the regulatory status of FLIX-EMS?

    FLIX-EMS has FDA 510(k) clearance with product code NGX. It was received by the FDA on May 31, 2018, and cleared on May 14, 2019, under the decision code SESE indicating substantial equivalence.

  • Who manufactures FLIX-EMS and where is it supplied from?

    FLIX-EMS is manufactured and supplied by Casgarum Investment, S.L., located in Illescas, Spain. The company's address is Calle Real, 17 Bº E, with postal code 45200.

  • Is FLIX-EMS a single-use or reusable device?

    The device data does not specify whether FLIX-EMS is designed for single-use or multiple uses. No information regarding sterility or single-use/reusable status is provided in the available documentation.