Data / Medical devices / United States / Bio-Research Associates, Inc.
Bio-Research Associates, Inc.: FDA-registered device maker in Mequon, WI, United States, 6 510(k) clearances
Bio-Research Associates, Inc. is registered with the FDA (registration 2183552) in Mequon, WI, United States. It lists 4 device types. The FDA files 6 510(k) clearances under its listings, the newest dated July 25, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2183552
- Address
- 12308 Corporate Pkwy Ste 450, Mequon, WI, United States, 53092
- Owner or operator
- Bioresearch (2183552)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- May 18, 2006
- Registered through
- 2026
- Brand names listed
- BioEMG III, BioJVA, BioJVA Wireless, BioPAK, JT-3, M-Scan, QuadraTENS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Dental Sonography, For Monitoring Jaw Sounds | NFQ | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Device, Jaw Tracking, For Monitoring Jaw Positions | NFS | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Device, Muscle Monitoring | KZM | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| July 25, 2013 | K130158 | M-SCAN | KZM | Substantially Equivalent | Bio-Research Associates, Inc. | accessdata.fda.gov |
| February 6, 2009 | K082927 | BIOEMG III | KZM | Substantially Equivalent | Bio-Research Associates, Inc. | accessdata.fda.gov |
| August 28, 2006 | K061799 | QUADRATENS, MODEL QT-42 | GZJ | Substantially Equivalent | Bio-Research Associates, Inc. | accessdata.fda.gov |
| September 15, 1998 | K981563 | BIOPAK MEASUREMENT SYSTEM | KZM | Substantially Equivalent | Bio-Research Associates, Inc. | accessdata.fda.gov |
| September 21, 1995 | K952218 | JT-3 ELECTROGNATHOGRAPH | NFS | Substantially Equivalent | Bio-Research Associates, Inc. | accessdata.fda.gov |
| May 15, 1991 | K905657 | SONOPAK/QS, SONOPAK | NFQ | Substantially Equivalent | Bioresearch | accessdata.fda.gov |
Compare with other makers
- All makers of Device, Muscle Monitoring
- All makers of Device, Dental Sonography, For Monitoring Jaw Sounds
- All makers of Device, Jaw Tracking, For Monitoring Jaw Positions
- All makers of Stimulator, Nerve, Transcutaneous, For Pain Relief
Updated July 25, 2013. 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.