Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012484616

FEI Number

3012484616

Entity Name

ENABLE INJECTIONS

City/State/Country

Cincinnati, OH, US

Establishment Address

2863 East Sharon Road, Cincinnati, OH 45241, US

Establishment Type(s)

Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Enable Injections (Owner Number: 10079664)

Owner / Operator Contact Address

2863 East Sharon Road, Cincinnati, OH 45241, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Empaveli Injector

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QLF	On-Body Injector	General Hospital	Class 2	880.5860	2023-10-11

Official Correspondent

Symone Whittaker

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Enable Injections

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012484616. Last updated year: 2026. Please use registration number 3012484616 when referencing this establishment in official correspondence.