# K983550: Xyz System

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Monitoring International Corp.
- Decided: Jan 7, 1999 after 90 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 K945826 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945826: J & J I-330 Series Physiological Monitoring & Biofeedback Instument and Use Software Applications, Medical Device Inspection Co., Inc. (1995). Our OCR of the scanned summary read K245826, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “J&J Physicdata 1-330 System”.

## Indications for use
The XYZ System is intended for biofeedback for relaxation and re-education of muscles.

Source page: https://510kreport.com/device/K983550
Methodology: https://510kreport.com/methodology