Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027037494

FEI Number

3027037494

Entity Name

TYMPA HEALTH TECHNOLOGIES INC

City/State/Country

Miami, FL, US

Establishment Address

777 Brickell Avenue, Suite 582, Miami, FL 33131, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Tympa Health Technologies inc (Owner Number: 10087664)

Owner / Operator Contact Address

777 Brickell Ave Suite 582, Miami, FL 33131, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Tympa Otoscope System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2025-11-20

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Tympa Health Technologies inc

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
K932506	Rudolf Riester GmbH & Co. KG	RI-SCOPE (S)	1993-10-08

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027037494. Last updated year: 2026. Please use registration number 3027037494 when referencing this establishment in official correspondence.