Data / Medical devices / System, Gastrointestinal Motility (Electrical) / United States
FDA-registered makers of System, Gastrointestinal Motility (Electrical) in the United States: 10 establishments
10 establishments in the United States are registered with the FDA to make System, Gastrointestinal Motility (Electrical) (product code FFX). 7 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 2, 2026.
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- Device
- System, Gastrointestinal Motility (Electrical)
- Product code
- FFX
- Country
- United States
Makers of System, Gastrointestinal Motility (Electrical) in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Laborie Medical Technologies Corp. | Portsmouth, NH, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 8 | May 6, 2024 | 0 | 1 | 0 | api.fda.gov |
| Diversatek Healthcare Inc. | Highlands Ranch, CO, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 4 | October 3, 2019 | 0 | 3 | 0 | api.fda.gov |
| Anx Robotica Corp. | Plano, TX, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 2 | May 21, 2020 | 0 | 0 | 0 | api.fda.gov |
| Covidien llc | Santa Clara, CA, United States | Specification developer | 2 | July 21, 2023 | 0 | 1 | 0 | api.fda.gov |
| Konsyl Pharmaceuticals, Inc. | Easton, MD, United States | Manufacturer, Specification developer | 2 | November 15, 2018 | 0 | 0 | 0 | api.fda.gov |
| Covidien | Plainfield, IN, United States | Manufacturer | 1 | July 21, 2023 | 0 | 0 | 0 | api.fda.gov |
| Medspira LLC | Minneapolis, MN, United States | Manufacturer | 1 | December 5, 2025 | 0 | 0 | 0 | api.fda.gov |
| Fermatex Vascular Technologies D.B.A. Adam Spence | Wall, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Neuraxis, Inc | Carmel, IN, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rose Medical | Grand Rapids, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.