# K170835: Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE

- Pathway: 510(k) (Traditional)
- Applicant: Hightech Development
- Decided: Jun 15, 2018 after 452 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Electro Antiperspirant, Electro Antiperspirant Sensitive, and the Electro Antiperspirant ELITE are tap water iontophoresis devices intended to treat hyperhidrosis (excessive 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/K170835
Methodology: https://510kreport.com/methodology