BIO-RESEARCH ASSOCIATES, INC.

FDA Device Registration & Listing · Mequon, WI, US · Registration 2183552

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2183552
FEI Number
2183552
Entity Name
BIO-RESEARCH ASSOCIATES, INC.
City/State/Country
Mequon, WI, US
Establishment Address
12308 Corporate Pkwy Ste 450, Mequon, WI 53092, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
Bioresearch (Owner Number: 2183552)
Owner / Operator Contact Address
12308 Corporate Pkwy, Suite 450, Mequon, WI 53092, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K082927
PMA Number
N/A

All Registered Proprietary Names

M-Scan QuadraTENS BioJVA Wireless BioJVA BioPAK BioEMG III

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KZM Device, Muscle Monitoring Physical Medicine Class 2 890.1375 2013-08-09
GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief Neurology Class 2 882.5890 2008-01-22
NFQ Device, Dental Sonography, For Monitoring Jaw Sounds Dental Class 1 872.2050 2026-05-04
NFQ Device, Dental Sonography, For Monitoring Jaw Sounds Dental Class 1 872.2050 2008-01-22
KZM Device, Muscle Monitoring Physical Medicine Class 2 890.1375 2008-01-22
NFQ Device, Dental Sonography, For Monitoring Jaw Sounds Dental Class 1 872.2050 2008-01-22
NFS Device, Jaw Tracking, For Monitoring Jaw Positions Dental Class 1 872.2060 2008-01-22
KZM Device, Muscle Monitoring Physical Medicine Class 2 890.1375 2013-04-11

Official Correspondent

Angela Habermann

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Bioresearch
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K122948 Gemore Technology Co, Ltd. GEM-STIM COMBO STIMULATOR 2012-12-21
K033455 Biomedical Life Systems, Inc. ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5 2004-01-15
K810593 Medical Devices, Inc. NEUROPAC ULTRA I 1981-03-13

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2183552. Last updated year: 2026. Please use registration number 2183552 when referencing this establishment in official correspondence.
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