Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2132556

FEI Number

1000221051

Entity Name

PEPIN MFG., INC.

City/State/Country

LAKE CITY, MN, US

Establishment Address

1875 HWY 61 SOUTH, LAKE CITY, MN 55041, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

PEPIN MFG., INC. (Owner Number: 9007792)

Owner / Operator Contact Address

1875 HWY 61 SOUTH, --, Lake City, MN 55041, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

DuraFuse CUTANEOUS ELECTROTHERAPY AdvanTrode®

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2015-09-23
MZR	Topical Approximation System	General Hospital	Class 1	880.5240	2023-02-03
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2015-09-23
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2023-03-13
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2015-09-23
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2007-08-10
MKY	System, Skin Closure	General, Plastic Surgery	Class 1	878.4320	2023-02-03

Official Correspondent

Melissa Ryan

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PEPIN MFG., 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
K913749	Edentec Corp.	EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170	1992-07-02
K771407	Research Development Corp.	LUNG VOLUME & PRESSURE MONITOR	1977-08-04
K122223	Philips Medizin Systeme Boeblingen GmbH	NEW: INTELLIVUE CL RESPIRATION POD NEW: SPECIALIZED ASSESSORY: MOBILE CL RESP ATTACHMENT MODIFIED: INTELLIVUE PATIENT MO	2013-04-12
K082968	Apneicare, LLC	APNEICARE CONNECTION CENTER/INTERNET ANALYSIS	2009-01-02
K070612	Top-Rank Health Care Equipment Co., Ltd.	TOP-RANK ADHESIVE ELECTRODE	2007-05-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2022	NOX MEDICAL Keldnaholt Reykjavik Iceland	2	Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.

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3017760831	Hi-P ELECTRONICS (MALAYSIA) SDN. BHD.	Kulim Kedah, MY

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2132556. Last updated year: 2026. Please use registration number 2132556 when referencing this establishment in official correspondence.