Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042023384

FEI Number

3042023384

Entity Name

FFX Inc.

City/State/Country

Hopkins, MN, US

Establishment Address

607 Plymouth Rd, Hopkins, MN 55305, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

FFX Inc. (Owner Number: 10094227)

Owner / Operator Contact Address

651 N. Broad St., Suite 201, Middletown, DE 19709, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Bullring BigBull

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LKY	Device, External Penile Rigidity	Gastroenterology, Urology	Class 2	876.5020	2025-11-19

Official Correspondent

Robert Strong

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

FFX Inc.

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 3042023384. Last updated year: 2026. Please use registration number 3042023384 when referencing this establishment in official correspondence.