Reflux
Reflux software v6.1 upgrade
1manufacturer
2catalogue numbers in this listing
1510(k) clearance
2recalls on this code
Who Else Makes It
Registered in Chongqing.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Chongqing Jinshan Science & Technology (Group) Co., Ltd. | Chongqing | Chongqing | Manufacturer | 4 |
Record
| Listed by | Given Imaging Ltd., Israel |
|---|---|
| FDA product code | FFT |
| Device type | Electrode, Ph, Stomach |
| Device class | Class 1 |
| Regulation | 21 CFR 876.1400 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-06-20 |
| Record revised | 2024-11-15 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FGS-0656 | In distribution | |
| FGS-0657 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Diversatek Healthcare | Diversatek Healthcare Inc | 36 |
| Versaflex | Given Imaging Ltd. | 35 |
| Bravo | Given Imaging Ltd. | 9 |
| Heidelberg pH Capsule System | Heidelberg Medical Inc | 7 |
| Restech | THE Reflux Company | 6 |
| alpHaONE | Chongqing Jinshan Science & Technology (Group) Co., Ltd. | 4 |
| Electrode, Ph, Stomach | Given Imaging Ltd. | 3 |
| 2 channel pH antimony, 21 cm spacing, 6.4 Fr | Medical Measurement Systems B.V. | 1 |
| 2 channel pH antimony, 15 cm spacing, 6.4 Fr | Medical Measurement Systems B.V. | 1 |
| 2 channel pH antimony, 10 cm spacing, 6.4 Fr | Medical Measurement Systems B.V. | 1 |
| 1 channel pH antimony, 6.4 Fr | Medical Measurement Systems B.V. | 1 |
| Digitrapper | Given Imaging Ltd. | 1 |
Showing 12 of 14. All products under Electrode, Ph, Stomach
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K102543 | 2010-12-01 |
Recalls
1 of these is Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2026-08-06 | Not classified | Nonconforming Material/Component | Capsule may fail to attach to the esophagus or detach from the delivery device. Risks include patient aspiration/inhalation, perforation of esophagus, obstruction of the airway, hemorrhage/blood loss/bleeding, laceration of the esophagus, a | 127,416 |
| 2025-06-03 | Class I | Process control | It has been determined that misapplied adhesive on the Bravo CF capsule delivery device may lead to its malfunction. Specifically, the misapplied adhesive may prevent the capsule from attaching to the patient’s esophagus or detaching from t | 128,202 units |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.