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Hidroxa SE30 Iontophoresis Device

by Hidroxa Medical AB

510(k) K241267

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K241267↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK241267 Date17 Oct 2024ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Full name
Hidroxa SE30
510(k) Number
FDA Product Code
EGJ
Device Class
Class II
Regulation
21 CFR Part 890.5525
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 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 Hidroxa SE30 is a Device, Iontophoresis as classified under 21 CFR 890.5525, designed for transdermal delivery of therapeutic agents via low-voltage electrical current. It facilitates iontophoresis, a non-invasive technique used to enhance the penetration of medications such as lidocaine, dexamethasone, or other ionic substances into the skin for localized treatment.

This device is supplied as a reusable medical instrument, intended for use in clinical settings such as physical medicine and rehabilitation. It operates under sterile conditions when in direct contact with the patient and is regulated under FDA 510(k) clearance (K241267) and the EU Medical Device Regulation (MDR). The Hidroxa SE30 adheres to Class II special controls and is manufactured by Hidroxa Medical AB, Partille, Sweden.

Other devices from Hidroxa Medical AB

  • Hidroxa SE30

    Class IIa

Questions

AI-generated answers, 18 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 clinical specialties is the Hidroxa SE30 primarily intended for use in, and why?

    The Hidroxa SE30 is primarily intended for use in physical medicine and rehabilitation settings, as indicated by its classification under 21 CFR 890.5525 and the advisory committee designation for Physical Medicine (PM) during its FDA review. This device is designed to assist in non-invasive transdermal delivery of medications like lidocaine or dexamethasone, making it particularly relevant for pain management, inflammation control, or muscle/spasm treatment in these specialties.

  • Is the Hidroxa SE30 a single-use or reusable device, and how does this affect its clinical workflow?

    The Hidroxa SE30 is explicitly described as a reusable medical instrument, meaning it is intended for repeated use in clinical settings after proper cleaning and maintenance. This design allows for cost-effective integration into workflows where multiple patients may benefit from iontophoresis sessions, though clinicians must follow manufacturer guidelines to ensure sterility during patient contact (e.g., disposable electrodes or sterile covers may be required per protocol).

  • What regulatory pathways has the Hidroxa SE30 undergone, and what does this mean for its use in the U.S. and EU?

    The Hidroxa SE30 has received FDA 510(k) clearance (K241267) under the Traditional 510(k) pathway, demonstrating it is classified as Substantially Equivalent to a predicate device. Additionally, it complies with the EU Medical Device Regulation (MDR), indicating it meets stringent EU safety and performance requirements. Clinicians in the U.S. can rely on its FDA clearance for use in physical medicine, while EU users can trust its MDR compliance for legal market placement.

  • How does the device ensure sterility during patient use, given it is reusable?

    While the Hidroxa SE30 itself is a reusable instrument, its sterility during patient contact is maintained through proper clinical protocols—such as using sterile electrodes, gel, or disposable covers—as implied by its classification as a reusable device intended for sterile application. The manufacturer’s instructions (not detailed here) would outline specific cleaning, disinfection, and sterilization steps to prevent cross-contamination between uses.

  • What types of therapeutic agents can be delivered via the Hidroxa SE30, and how does this influence its versatility?

    The Hidroxa SE30 is designed for transdermal delivery of ionic substances, including medications like lidocaine (for local anesthesia) or dexamethasone (for anti-inflammatory effects), as well as other approved ionic compounds. This versatility makes it suitable for treating conditions such as muscle spasms, joint pain, or localized edema in physical medicine, though the specific agents must comply with iontophoresis guidelines and be prescribed by a clinician.