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510(k) K241267

Device
Hidroxa SE30
Applicant
Hidroxa Medical AB
510(k) number
K241267
Product code
EGJ
Decision
Substantially Equivalent (SESE)
Decision date
2024-10-17
Date received
2024-05-06
Regulation
890.5525
Classification name
Device, Iontophoresis, Other Uses
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Sandra Eriksson Mirkovic
Address
Bjorndammsterrassen 114 Partille SE 43342 43342

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code EGJ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K242041STOPWET iontophoresis apparatus (SW01)Taiwan Medical Electronics Co., Ltd.2025-04-01
K232020Iontophoresis ElectrodesTop-Rank Health Care Co., Ltd.2023-10-16
K192749DermadryDermadry Laboratories, Inc.2020-02-10
K191436SaalioSaalmann Medical GmbH & Co. KG2019-10-18
K170835Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITEHightech Development2018-06-15
K170291IontoDCSoterix Medical, Inc.2017-05-01
K150453TULA Iontophoresis System with EarsetAcclarent, Inc.2015-05-20
K133033HIDREX PSP1000Hidrex GmbH2015-04-08
K132832ACTIVAPATCH ET IONTOPHORESIS PATCHActivatek, Inc.2014-02-13
K110636TULA IONTOPHORESIS SYSTEMAcclarent, Inc.2011-06-16
K083016ACTHYDERMMicrolab Americas, Inc.2009-06-16
K091326ACTIVAPATCHActivatek, Inc.2009-05-27
K080580COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MODEL SMALL DDS275, MEDIUM DDM325, LARGE DAxelgaard Mfg. Co., Ltd.2008-06-18
K073276IONTOPHORESIS SYSTEMAcclarent, Inc.2008-03-05
K072946HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEMEmpi2007-11-16