Iontophoretic Drug Delivery Electrode, Iontophoretic Electrode (Active)
FDA 510(k) K000574 · Wr Medical Electronics Co.
510(k) numberK000574
Submission
- Device name
- Iontophoretic Drug Delivery Electrode, Iontophoretic Electrode (Active)
- Applicant
- Wr Medical Electronics Co.
Stillwater, MN, US - Received
- February 22, 2000
- Decision date
- August 9, 2000
- 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 |
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| 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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Questions and answers
When was Iontophoretic Drug Delivery Electrode, Iontophoretic Electrode (Active) cleared by the FDA?
Iontophoretic Drug Delivery Electrode, Iontophoretic Electrode (Active) (K000574) received a 510(k) decision of Substantially Equivalent on August 9, 2000, 169 days after the submission was received.
What is the product code of K000574?
The FDA product code is EGJ – Device, Iontophoresis, Other Uses, a Class II (moderate risk) device regulated under 21 CFR 890.5525.