Iontophoresis Device - Electrode RH 800
FDA 510(k) K896444 · Iomed, Inc.
510(k) numberK896444
Submission
- Device name
- Iontophoresis Device - Electrode RH 800
- Applicant
- Iomed, Inc.
Salt Lake City, UT, US - Received
- November 9, 1989
- Decision date
- May 10, 1990
- Decision
- Unknown (SESD)
- Type
- Traditional 510(k)
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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More from Activatek, Inc.
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| 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 - Electrode RH 800 cleared by the FDA?
Iontophoresis Device - Electrode RH 800 (K896444) received a 510(k) decision of Unknown on May 10, 1990, 182 days after the submission was received.
What is the product code of K896444?
The FDA product code is EGJ – Device, Iontophoresis, Other Uses, a Class II (moderate risk) device regulated under 21 CFR 890.5525.