Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011276311

FEI Number

3011276311

Entity Name

BIO-THESIOMETER USA

City/State/Country

Westlake, OH, US

Establishment Address

24511 Hedgewood Way, Westlake, OH 44145, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Brawner-Dyke, LLC (Owner Number: 10048217)

Owner / Operator Contact Address

451 Waterside Drive, Avon Lake, OH 44012, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Bio-Thesiometer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LLN	Device, Vibration Threshold Measurement	Neurology	Class 1	882.1200	2014-12-17

Official Correspondent

Franklin Brawner

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Brawner-Dyke, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011276311. Last updated year: 2026. Please use registration number 3011276311 when referencing this establishment in official correspondence.