Iontophoresis Device, Modification
FDA 510(k) K914621 · Iomed, Inc.
510(k) numberK914621
Submission
- Device name
- Iontophoresis Device, Modification
- Applicant
- Iomed, Inc.
Salt Lake City, UT, US - Received
- September 11, 1991
- Decision date
- December 20, 1991
- Decision
- Unknown (SEKD)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K063465 | Champion Iontophoretic Drug Delivery DeviceEGJ · Traditional | 02/28/2007SE |
| K060236 | MW-1000 Iontophoretic Drug Delivery ElectrodeEGJ · Traditional | 03/31/2006SE |
| K033192 | RH-950KTB · Traditional | 12/22/2003SE |
| K031115 | RH-900KTB · Traditional | 07/10/2003SE |
| K001522 | TRANSQ3KTB · Traditional | 10/18/2000SE |
| K001410 | Phoresor Model PM2000KTB · Traditional | 08/01/2000SE |
| K982668 | Phoresor Ii,Model PM900EGJ · Traditional | 03/02/1999SE |
| K974855 | Phoresor II, Model PM900KTB · Traditional | 03/27/1998SN |
| K954126 | Transq Electrode Phoresor IIKTB · Traditional | 01/19/1996SN |
| K934335 | Phoresor II Auto, Model PM800 ModificationEGJ · Traditional | 07/26/1994SE |
Questions and answers
When was Iontophoresis Device, Modification cleared by the FDA?
Iontophoresis Device, Modification (K914621) received a 510(k) decision of Unknown on December 20, 1991, 100 days after the submission was received.
What is the product code of K914621?
The FDA product code is EGJ – Device, Iontophoresis, Other Uses, a Class II (moderate risk) device regulated under 21 CFR 890.5525.