Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009495681

FEI Number

3009495681

Entity Name

EPSIMED LLC

City/State/Country

Miami, FL, US

Establishment Address

13230 Sw 132nd Ave # B21, Miami, FL 33186, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

EPSIMED LLC (Owner Number: 10039670)

Owner / Operator Contact Address

13230 SW 132 ave #B21, Miami, FL 33186, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K212434

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KOI	Stimulator, Nerve, Peripheral, Electric	Anesthesiology	Class 2	868.2775	2026-03-26

Official Correspondent

William Mena

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

EPSIMED 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 3009495681. Last updated year: 2026. Please use registration number 3009495681 when referencing this establishment in official correspondence.