510(k) K031053
- Device
- SELECTIVE MED COMPONENTS, INC. BUFFERED IONTOPHORESIS DRUG DELIVERY SYSTEM ELECTRODES, MODELS I20, I30, I40, I50, AND I7
- Applicant
- SELECTIVE MED COMPONENTS, INC.
- 510(k) number
- K031053
- Product code
- EGJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-05-20
- Date received
- 2003-04-02
- 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
- RICHARD J FISHER
- Address
- 201 W. High St. Mount Vernon OH US 43050 43050
FDA Registration Numbers#
- 9680612
- 3022698313
- 3009736547
- 3012182497
- 1721293
- 3006626283
- 2118418
- 3016463808
- 3013399500
- 3015099059
- 2183164
- 3016087653
- 2182681
- 2025066
- 3008642982
- 3003749270
- 2030624
- 3012316249
- 3017264244
- 2939821
Source Documents#
Other 510(k) Records For Product Code EGJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242041 | STOPWET iontophoresis apparatus (SW01) | Taiwan Medical Electronics Co., Ltd. | 2025-04-01 |
| K241267 | Hidroxa SE30 | Hidroxa Medical AB | 2024-10-17 |
| K232020 | Iontophoresis Electrodes | Top-Rank Health Care Co., Ltd. | 2023-10-16 |
| K192749 | Dermadry | Dermadry Laboratories, Inc. | 2020-02-10 |
| K191436 | Saalio | Saalmann Medical GmbH & Co. KG | 2019-10-18 |
| K170835 | Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE | Hightech Development | 2018-06-15 |
| K170291 | IontoDC | Soterix Medical, Inc. | 2017-05-01 |
| K150453 | TULA Iontophoresis System with Earset | Acclarent, Inc. | 2015-05-20 |
| K133033 | HIDREX PSP1000 | Hidrex GmbH | 2015-04-08 |
| K132832 | ACTIVAPATCH ET IONTOPHORESIS PATCH | Activatek, Inc. | 2014-02-13 |
| K110636 | TULA IONTOPHORESIS SYSTEM | Acclarent, Inc. | 2011-06-16 |
| K083016 | ACTHYDERM | Microlab Americas, Inc. | 2009-06-16 |
| K091326 | ACTIVAPATCH | Activatek, Inc. | 2009-05-27 |
| K080580 | COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MODEL SMALL DDS275, MEDIUM DDM325, LARGE D | Axelgaard Mfg. Co., Ltd. | 2008-06-18 |
| K073276 | IONTOPHORESIS SYSTEM | Acclarent, Inc. | 2008-03-05 |
Legacy Summary#
summary
FDA Review#
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