# K980373: Ultramind Biofeedback System with DE-Stress Software

- Pathway: 510(k) (Traditional)
- Applicant: Ultramind International, Ltd.
- Decided: Apr 29, 1998 after 89 days
- Product code: HCC (Device, Biofeedback)
- Device class: 2
- Regulation: 21 CFR 882.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K951213 (1995). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951213: Relaxplus, Ultramind International, Ltd. (1995) Summary page 2.

## Most influential descendants
- K071866: Ntrainer System (2008), 1 descendant of its own
- K143507: NFANT Feeding Solution (2015), 0 descendants of its own

## Indications for use
The Ultramind Biofeedback System with de-STRESS Software is a biofeedback system designed to be used for relaxation training.

Source page: https://510kreport.com/device/K980373
Methodology: https://510kreport.com/methodology