# K091326: Activapatch

- Pathway: 510(k) (Traditional)
- Applicant: Activatek, Inc.
- Decided: May 27, 2009 after 22 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: 5 generations back to K912015 (1991). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061522: Trivarion Buffered Iontophoresis Electrode System, Activatek, Inc. (2006) Summary page 1.
- K030395: Empi Action Patch Iontophoresis System, Empi (2003) Summary page 1.

## Indications for use
The ActivaTek ActivaPatch Jontophoresis System is intended to be used for the administration of soluble salts into the body for medical purposes and as an alternative to hypodermic injection.

Source page: https://510kreport.com/device/K091326
Methodology: https://510kreport.com/methodology