# K133033: Hidrex PSP1000

- Pathway: 510(k) (Traditional)
- Applicant: Hidrex GmbH
- Decided: Apr 8, 2015 after 559 days
- Product code: EGJ (Device, Iontophoresis, Other Uses)
- Device class: 2
- Regulation: 21 CFR 890.5525
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K831320 (1983). 2 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964208: MD-1A Galvanic Unit, R. A. Fischer Co. Corp. (1997) Summary page 4.
- K831320: Drionic, General Medical Co. (1983) Summary page 4.

## Most influential descendants
- K192749: Dermadry (2020), 1 descendant of its own
- K242041: STOPWET iontophoresis apparatus (SW01) (2025), 0 descendants of its own
- K241267: Hidroxa SE30 (2024), 0 descendants of its own
- K191436: Saalio (2019), 0 descendants of its own

## Recalls of this device
- Jan 30, 2017 · Class III · Z-1238-2017: The device was reclassified from a class III device to a class II device and there are new documentation requirements.
- Jan 30, 2017 · Class III · Z-1237-2017: The device was reclassified from a class III device to a class II device and there are new documentation requirements.
- Jan 30, 2017 · Class III · Z-1236-2017: The device was reclassified from a class III device to a class II device and there are new documentation requirements.

## Indications for use
This Tap-Water-Iontophoresis device is 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/K133033
Methodology: https://510kreport.com/methodology