# K020476: Medion 6000

- Pathway: 510(k) (Traditional)
- Applicant: Selectivemed Components, Inc.
- Decided: May 3, 2002 after 80 days
- Product code: EGJ (Device, Iontophoresis, Other Uses)
- Device class: 2
- Regulation: 21 CFR 890.5525
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K934335 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982668: Phoresor II,Model PM900, Iomed, Inc. (1999) Summary page 1.
- K895365: MD-2 Iontophoresis Unit, R. A. Fischer Co. Corp. (1990) Summary page 1.

## Cited in the summary but kept off the family tree
- K933445: DPS 100 Multiport Illumination System (Mis), Storz Instrument Co. (1994). Our OCR of the scanned summary read K933445, FDA’s number for DPS 100 Multiport Illumination System (Mis) (Storz Instrument Co.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Iomed Phoresor I Model PM 800”. Kept off the family tree. Summary page 1.

## Indications for use
Intended to use a direct current to introduce ions of soluble salts or other drugs into the body for medical purposes, as an alternative to hypodermic injection when it is advisable to avoid the pain that may accompany needle insertion and drug injection, and when it is advisable to minimize the infiltration of carrier fluids or to avoid the damage that may be caused by needle insertion when tissue is traumatized.

Source page: https://510kreport.com/device/K020476
Methodology: https://510kreport.com/methodology