# K191436: Saalio

- Pathway: 510(k) (Traditional)
- Applicant: Saalmann Medical GmbH & Co. KG
- Decided: Oct 18, 2019 after 141 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 K831320 (1983). 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)
- K133033: Hidrex PSP1000, Hidrex GmbH (2015) Summary page 4.

## Indications for use
Tap water iontophoresis device intended to treat hyperhidrosis (pathological sweating) affecting hands, feet, and underarms. Any other use or usage beyond this scope is considered un-intended use and may have dangerous consequences.

Source page: https://510kreport.com/device/K191436
Methodology: https://510kreport.com/methodology