refluxcompany.com
restech.comReflux Band - External upper-esophageal sphincter compression device.
2026-10-08
THE REFLUX COMPANY
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3039167637 | 3039167637 | THE REFLUX COMPANY | 1 | N | 2026-01-01 | 7868 Silverton Ave Ste J San Diego CA US 92126 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00866736000307 | Reflux Band - External upper-esophageal sphincter compression device. | 858-397-2200 | contact@refluxcompany.com |
| 00866736000314 | Reflux Band Manometer - Manometer used in fitting the Reflux Band. | 858-397-2200 | contact@refluxcompany.com |
| 00866736000383 | Reflux Band Pressure Sensor - Pressure transducer used in fitting the Reflux Band. | 858-397-2200 | contact@refluxcompany.com |
| 00899994002097 | Restech - pH probe. Intended for oropharyngeal pH measurement. | 858-673-3700 | Customerservice@restech.com |
| 00899994002097 | Restech - pH probe. Intended for oropharyngeal pH measurement. | 858-397-2200 | contact@refluxcompany.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 341190 | 1569082513 | K173934 | Reza Band, Reflux Band | PKA | 2018-04-13 |
| 341190 | 1876304186 | K152317 | Stretta Catheter | GEI | 2015-09-23 |
| 341190 | 1841905386 | K014216 | SECCA SYSTEM | GEI | 2002-03-21 |
| 341190 | 1011196009 | ||||
| 341190 | 1543474534 |
Product Codes Associated With Registrations#
GUDID#
Reflux Band Manometer - Manometer used in fitting the Reflux Band.
2026-10-08
Reflux Band Pressure Sensor - Pressure transducer used in fitting the Reflux Band.
2026-10-08
Restech - pH probe. Intended for oropharyngeal pH measurement.
2022-12-02
Restech - The Restech Dx–pH Measurement System is intended for gastroesophageal pH measurement and monitoring of gastric reflux. The pH data Recorder and data viewing program are intended for gastroesophageal pH data acquisition and analysis to diagnose reflux disorders.
2022-12-02
Restech - Dx-300 Transmitter - Part of the Dx-1000 pH Measurement System. The transmitter is intended for gastroesophageal pH data acquisition and analysis to diagnose reflux disorders.
2022-12-02
Restech - Dx-500 Recorder - Part of the Dx-1000 pH Measurement system. The pH data Recorder is intended for gastroesophageal pH data acquisition and analysis to diagnose reflux disorders.
2022-12-02
Restech - Primus pH probe. Intended for oropharyngeal pH measurement.
2022-12-02
Restech - Long pH probe for esophageal pH measurement.
2022-12-02
Mederi MDRF1 Generator - Mederi MDRF1 Generator Monopolar generator to be used only with Secca and Stretta catheters
2016-09-27
Stretta - Stretta Catheter and Accessory Kit for use only with Mederi MDRF1 Generator
2016-09-27
Secca - Secca Handpiece and Accessory Kit for use only with the Mederi MDRF1 Generator
2016-09-27