# K031769: E-Strip

- Pathway: 510(k) (Traditional)
- Applicant: Eemso, Inc.
- Decided: Oct 14, 2003 after 127 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: 1 generation back to K872040 (1987). 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)
- K872040: Phoresor II (TM), Model PM700, Motion Control, Inc. (1987) Summary page 1.
- K914264: Transq 2, Iomed, Inc. (1991) Summary page 1.
- K992708: Iontopatch, Birch Point Medical, Inc. (2000) Summary page 1.
- (no number) Life-Tech Iontophor II Model 6111 PMDX with Meditrode electrodes: named in the summary without a submission number

## Indications for use
The E-STRIP device is intended to use a direct current to introduce ions of soluble salts or other drugs into the body for medical purposes.

Source page: https://510kreport.com/device/K031769
Methodology: https://510kreport.com/methodology