# K212954: G-Tech Wireless Patch System (WPS)

- Pathway: 510(k) (Traditional)
- Applicant: G-Tech Medical
- Decided: Jan 10, 2022 after 116 days
- Product code: MYE (System, Electrogastrography (Egg))
- Device class: 2
- Regulation: 21 CFR 876.1735
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN990005 (1999). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN990005: The 3PM Egg Machine, 3pm Co., Inc. (1999). Our reading of the summary gave K984637, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN990005, The 3PM Egg Machine (3pm Co., Inc.), granted Aug 20, 1999; older De Novo requests were first filed under a 510(k) number, so this links to the grant. Summary page 4.
- K014269: Polygram Net Electrogastrography Application Software, Model 9043S0151; Polygraf ID, Model 9043G0102, Medtronic Functional Diagnostics A/S (2002) Summary page 4.

## Indications for use
The intended use for the G-Tech Patch System is to serve as a tool that provides gastrointestinal myoelectrical activity measurements to be used at the discretion of the Physician or Clinical User to aid in the diagnosis and evaluation of gastrointestinal disorders.

Source page: https://510kreport.com/device/K212954
Methodology: https://510kreport.com/methodology