# K220056: iSyncWave

- Pathway: 510(k) (Traditional)
- Applicant: iMediSync, Inc.
- Decided: Aug 10, 2022 after 216 days
- Product code: GWQ (Full-Montage Standard Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K873535 (1987). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172735: WR19 System, Zeto, Inc. (2018) Summary page 4.

## Indications for use
The iSyncWave is intended for prescription use in a health care facility to acquire, transmit, display and store primarily EEG and optional auxiliary signals for adults and children, not including newborns.

Source page: https://510kreport.com/device/K220056
Methodology: https://510kreport.com/methodology