# K973590: Hemorrelief Device

- Pathway: 510(k) (Traditional)
- Applicant: A.Stein - Regulatory Affairs Consulting
- Decided: Feb 5, 1998 after 136 days
- Product code: LKX (Device, Thermal, Hemorrhoids)
- Device class: U
- 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 Hemorrelief device is intended to provide treatment for the relief of pain, itching, inflammation and bleeding of hemorrhoids by means of cryotherapy (controlled cold treatment).

Source page: https://510kreport.com/device/K973590
Methodology: https://510kreport.com/methodology