Data / Medical devices / United States / Twin River Group
Twin River Group: FDA-registered device maker in Trenton, NJ, United States, 11 510(k) clearances
Twin River Group is registered with the FDA (registration 3021422553) in Trenton, NJ, United States. It lists 9 device types. The FDA files 11 510(k) clearances under its listings, the newest dated August 27, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021422553
- Address
- 600 Perry St, Trenton, NJ, United States, 08618
- Owner or operator
- Twin River Group (10084893)
- Roles
- Manufacturer
- First device listed
- May 2, 2022
- Registered through
- 2026
- Brand names listed
- BRAUN THERMOMETOR, OMRON BLOOD PRESSURE, OMRON NERVE STIMULATOR, ORAL B CROSS ACTION, ORAL B IO TOOTHBRUSH HEAD, ORAL B Precision CLEAN, ORAL B Sensitive Clean (EB60) 10er, WATERPIK FLOSSER and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | 2 | Manufacturer | accessdata.fda.gov |
| Electrocardiograph | DPS | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Electrical, Transcutaneous, For Arthritis | NYN | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | 2 | Manufacturer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Manufacturer | accessdata.fda.gov |
| Toothbrush, Manual | EFW | 1 | Manufacturer | accessdata.fda.gov |
| Toothbrush, Powered | JEQ | 1 | Manufacturer | accessdata.fda.gov |
| Transmitters And Receivers, Electrocardiograph, Telephone | DXH | 2 | Manufacturer | accessdata.fda.gov |
| Unit, Oral Irrigation | EFS | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 27, 2020 | K200881 | Oral-B iO Test Drive Power Brush Trial Program Kit | JEQ | Substantially Equivalent | The Procter & Gamble Company | accessdata.fda.gov |
| March 14, 2019 | K182579 | Omron Model BP7900 Blood Pressure Monitor + EKG | DXN | Substantially Equivalent | Omron Healthcare, Inc. | accessdata.fda.gov |
| November 9, 2018 | K181992 | Heat Pain Pro | NUH | Substantially Equivalent | Omron Healthcare, Inc. | accessdata.fda.gov |
| March 1, 2016 | K152748 | Braun Thermoscan PRO 6000 Ear Thermometer | FLL | Substantially Equivalent | Kaz USA, Inc (A Subsidiary of Helen of Troy, Inc) | accessdata.fda.gov |
| September 15, 2014 | K141018 | ORAL-B TEST DRIVE POWER BRUSH TRIAL PROGRAM KIT, ORAL-B TEST DRIVE POWER TOOTHBRUSH KIT, ORAL-B TEST DRIVE REFILL KIT | JEQ | Substantially Equivalent | Procter & Gamble Co. | accessdata.fda.gov |
| June 21, 2012 | K121165 | BEAM BRUSH/BEAM APP | EFW | Substantially Equivalent | Beam Technologies, LLC | accessdata.fda.gov |
| August 2, 2006 | K061822 | OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH COMFIT CUFF, MODEL HEM 780 N3 | DXN | Substantially Equivalent | Omron Healthcare, Inc. | accessdata.fda.gov |
| June 5, 2006 | K061351 | ORAL-B SONIC COMPLETE | JEQ | Substantially Equivalent | Braun GmbH | accessdata.fda.gov |
| May 31, 2006 | K061199 | ORAL B PROFESSIONALCARE SERIES, ORAL B ADVANCEPOWER SERIES | JEQ | Substantially Equivalent | Braun GmbH | accessdata.fda.gov |
| July 2, 2004 | K040416 | SONICARE ADVANCE TOOTHBRUSH, MODEL 4900 | JEQ | Substantially Equivalent | Philips Oral Healthcare, Inc. | accessdata.fda.gov |
| April 21, 1981 | K810864 | WATER PIK ORAL HYGIENE CENTER | EFS | Substantially Equivalent | Teledyne, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Toothbrush, Powered
- All makers of Transmitters And Receivers, Electrocardiograph, Telephone
- All makers of Electrocardiograph
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Unit, Oral Irrigation
- All makers of Toothbrush, Manual
Updated August 27, 2020. 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.