Data / Medical devices / Electrode, Ph, Stomach
Electrode, Ph, Stomach (FFT): 7 FDA-registered makers in 5 countries
7 establishments in 5 countries are registered with the FDA to make Electrode, Ph, Stomach (product code FFT, Class 1, 21 CFR 876.1400). 2 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 49 510(k) clearances under this code, the latest on December 1, 2010, and lists 9 recall events (2 Class I). FDA data exported November 2, 2026.
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- Product code
- FFT
- Device class
- 1
- Regulation
- 876.1400
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| United States | 2 |
| Vietnam | 2 |
| Israel | 1 |
| Brazil | 1 |
| China | 1 |
Makers of Electrode, Ph, Stomach
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Diversatek Healthcare Inc. | Highlands Ranch, CO, United States | Contract manufacturer, Manufacturer, Specification developer | 2 | February 28, 2002 | 0 | 2 | 0 | api.fda.gov |
| Given Imaging Ltd. | Yoqneam Northern, Israel | Manufacturer | 1 | December 1, 2010 | 0 | 2 | 2 | api.fda.gov |
| Alacer Industria Eletronica Ltda | Sao Paulo, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Chongqing Jinshan Science & Technology (group) Co., Ltd | Chongqing, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diversatek Vietnam Company Limited | Ho Chi Minh City, Vietnam | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Given Imaging Vietnam Co., Ltd. | Ho Chi Minh City, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| The Reflux Company | San Diego, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated December 1, 2010. 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.