Dupel II Buffered Iontophoresis Electrodes
FDA 510(k) K970491 · Empi
510(k) numberK970491
Submission
- Device name
- Dupel II Buffered Iontophoresis Electrodes
- Applicant
- Empi
St. Paul, MN, US - Received
- February 10, 1997
- Decision date
- May 30, 1997
- 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
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| K232020 | Iontophoresis ElectrodesEGJ · Traditional | Top-Rank Health Care Co., Ltd. | 10/16/2023SE |
| K192749 | DermadryEGJ · Traditional | Dermadry Laboratories, Inc. | 02/10/2020SE |
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| 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 |
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| 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 |
| K030395 | Empi Action Patch Iontophoresis SystemEGJ · Traditional | 04/08/2003SE |
| K021100 | 300 PV Complete Electrotherapy SystemIPF · Traditional | 06/18/2002SE |
| K991991 | Dupel Iontophoresis SystemEGJ · Traditional | 09/10/1999SE |
Questions and answers
When was Dupel II Buffered Iontophoresis Electrodes cleared by the FDA?
Dupel II Buffered Iontophoresis Electrodes (K970491) received a 510(k) decision of Substantially Equivalent on May 30, 1997, 109 days after the submission was received.
What is the product code of K970491?
The FDA product code is EGJ – Device, Iontophoresis, Other Uses, a Class II (moderate risk) device regulated under 21 CFR 890.5525.