Medion 6000
FDA 510(k) K020476 · Selectivemed Components, Inc.
510(k) numberK020476
Submission
- Device name
- Medion 6000
- Applicant
- Selectivemed Components, Inc.
Mount Vernon, OH, US - Received
- February 12, 2002
- Decision date
- May 3, 2002
- 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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| 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 |
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More from Activatek, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K120922 | Guardian Dysphagia Dual Channel Nmes UnitIPF · Abbreviated | 02/07/2013SE |
| K083756 | Guardian 150 ElectrodeGXY · Traditional | 06/26/2009SE |
| K031053 | Selective Med Components, Inc. Buffered Iontophoresis Drug Delivery System Electrodes…EGJ · Traditional | 05/20/2003SE |
| K993081 | Io-DriveEGJ · Traditional | 03/03/2000SE |
| K946230 | Endura Reusable TENS and Nmes ElectrodesGZJ · Traditional | 12/22/1995SE |
| K945676 | Guardian Disposable TENS and Tens/Nmes ElectrodesGZJ · Traditional | 01/30/1995SE |
Questions and answers
When was Medion 6000 cleared by the FDA?
Medion 6000 (K020476) received a 510(k) decision of Substantially Equivalent on May 3, 2002, 80 days after the submission was received.
What is the product code of K020476?
The FDA product code is EGJ – Device, Iontophoresis, Other Uses, a Class II (moderate risk) device regulated under 21 CFR 890.5525.