Empi Action Patch Iontophoresis System
FDA 510(k) K030395 · Empi
510(k) numberK030395
Submission
- Device name
- Empi Action Patch Iontophoresis System
- Applicant
- Empi
Washington, DC, US - Received
- February 5, 2003
- Decision date
- April 8, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K093324 | Empi ContinuumIPF · Traditional | 03/05/2010SE |
| K090922 | Empi Active Transcutaneous Nerve StimulatorGZJ · Special | 06/05/2009SE |
| K072946 | Hybresis Iontophoresis Drug Delivery SystemEGJ · Special | 11/16/2007SE |
| K070427 | Dupel Transport Iontophoresis SystemEGJ · Traditional | 05/14/2007SE |
| K061650 | Select TENS, Model 4600SGZJ · Traditional | 01/22/2007SE |
| K041920 | Infinity Plus Electrotherapy SystemIPF · Traditional | 01/21/2005SE |
| K042057 | Infinity Electrotherapy SystemLIH · Traditional | 12/17/2004SE |
| K021100 | 300 PV Complete Electrotherapy SystemIPF · Traditional | 06/18/2002SE |
| K991991 | Dupel Iontophoresis SystemEGJ · Traditional | 09/10/1999SE |
| K983484 | Dupel B.L.U.E. Small Iontophoresis ElectrodeEGJ · Traditional | 12/28/1998SE |
Questions and answers
When was Empi Action Patch Iontophoresis System cleared by the FDA?
Empi Action Patch Iontophoresis System (K030395) received a 510(k) decision of Substantially Equivalent on April 8, 2003, 62 days after the submission was received.
What is the product code of K030395?
The FDA product code is EGJ – Device, Iontophoresis, Other Uses, a Class II (moderate risk) device regulated under 21 CFR 890.5525.