Santa Barbara Medco-Lantophoretic Applic
FDA 510(k) K842483 · Santa Barbara Medco, Inc.
510(k) numberK842483
Submission
- Device name
- Santa Barbara Medco-Lantophoretic Applic
- Applicant
- Santa Barbara Medco, Inc.
Santa Barbara, CA, US - Received
- June 25, 1984
- Decision date
- August 31, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- EGJ – Device, Iontophoresis, Other Uses
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5525
- Specialty
- Physical Medicine
Other 510(k)s with product code EGJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242041 | STOPWET iontophoresis apparatus (SW01)EGJ · Traditional | Taiwan Medical Electronics Co., Ltd. | 04/01/2025SE |
| K241267 | Hidroxa SE30EGJ · Traditional | Hidroxa Medical AB | 10/17/2024SE |
| K232020 | Iontophoresis ElectrodesEGJ · Traditional | Top-Rank Health Care Co., Ltd. | 10/16/2023SE |
| K192749 | DermadryEGJ · Traditional | Dermadry Laboratories, Inc. | 02/10/2020SE |
| K191436 | SaalioEGJ · Traditional | Saalmann Medical GmbH & Co. KG | 10/18/2019SE |
| K170835 | Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITEEGJ · Traditional | Hightech Development | 06/15/2018SE |
| K170291 | IontoDCEGJ · Traditional | Soterix Medical, Inc. | 05/01/2017SE |
| K150453 | TULA Iontophoresis System with EarsetEGJ · Special | Acclarent, Inc. | 05/20/2015SE |
| K133033 | Hidrex PSP1000EGJ · Traditional | Hidrex GmbH | 04/08/2015SE |
| K132832 | Activapatch Et Iontophoresis PatchEGJ · Traditional | Activatek, Inc. | 02/13/2014SE |
More from Activatek, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K850492 | Nasal Septal ButtonLFB · Traditional | 03/07/1985SE |
| K823921 | Physicians Choice Silicone Ear PuttyLDG · Traditional | 03/28/1983SE |
| K821187 | Medco Custom Ear Protector Mold KitEWD · Traditional | 05/27/1982SE |
| K812071 | RK IV Surgical BladesGES · Traditional | 08/31/1981SE |
| K812069 | Bores* Depth GaugeFTY · Traditional | 08/31/1981SE |
| K812070 | Bores* Adjustable Blade HolderGDZ · Traditional | 08/18/1981SE |
| K802638 | Otological Ventilation TubesETD · Traditional | 11/12/1980SE |
Questions and answers
When was Santa Barbara Medco-Lantophoretic Applic cleared by the FDA?
Santa Barbara Medco-Lantophoretic Applic (K842483) received a 510(k) decision of Substantially Equivalent on August 31, 1984, 67 days after the submission was received.
What is the product code of K842483?
The FDA product code is EGJ – Device, Iontophoresis, Other Uses, a Class II (moderate risk) device regulated under 21 CFR 890.5525.