Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1930027

FEI Number

1930027

Entity Name

KATECHO LLC

City/State/Country

DES MOINES, IA, US

Establishment Address

4020 GANNETT AVENUE., DES MOINES, IA 50321, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

KATECHO LLC (Owner Number: 1930027)

Owner / Operator Contact Address

4020 Gannett Avenue, --, Des Moines, IA 50321, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

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
NHI	Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief	Neurology	Class 2	882.5890	2023-02-27
NHI	Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief	Neurology	Class 2	882.5890	2024-07-10
HCC	Device, Biofeedback	Neurology	Class 2	882.5050	2021-12-02
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2025-09-24
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2023-02-24
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2022-08-30
MVK	Wearable Automated External Defibrillator	Unknown	Class 3	N/A	2024-09-11
MLN	Electrode, Electrocardiograph, Multi-Function	Cardiovascular	Class 2	870.2360	2018-02-21
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2018-02-21
LDD	Dc-Defibrillator, Low-Energy, (Including Paddles)	Cardiovascular	Class 2	870.5300	2020-08-13
DRO	Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)	Cardiovascular	Class 2	870.5550	2020-08-13
LIX	Aid, Cardiopulmonary Resuscitation	Cardiovascular	Class 2	870.5210	2020-08-13
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2020-08-13
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2025-09-24
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2025-09-24
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2022-01-14
DRO	Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)	Cardiovascular	Class 2	870.5550	2022-01-14
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2018-11-07
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2018-11-07
KNF	Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)	Obstetrics/Gynecology	Class 2	884.4160	2018-11-07
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2020-09-11
LBI	Unit, Neonatal Phototherapy	General Hospital	Class 2	880.5700	2021-12-02
OSP	Uterine Electromyographic Monitor	Obstetrics/Gynecology	Class 2	884.2720	2024-07-09
HGM	System, Monitoring, Perinatal	Obstetrics/Gynecology	Class 2	884.2740	2024-07-09
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2023-04-16
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2024-08-15
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2008-03-25
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2008-03-25
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2016-12-21
MLN	Electrode, Electrocardiograph, Multi-Function	Cardiovascular	Class 2	870.2360	2014-11-19
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2014-11-19
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2023-11-20
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2008-03-25
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2008-03-25
KNF	Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)	Obstetrics/Gynecology	Class 2	884.4160	2025-06-13
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2026-04-13
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2018-02-22
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2025-02-07
ISD	Exerciser, Measuring	Physical Medicine	Class 2	890.5360	2018-08-27
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2016-11-28
NSA	Over-The-Counter Automated External Defibrillator	Cardiovascular	Class 3	870.5310	2015-05-09
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2018-02-21
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2025-02-07
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2025-09-24
EWE	Protector, Hearing (Circumaural)	Unknown	Class U	N/A	2018-02-21
QVE	Adjunctive Pain Measurement Device For Anesthesiology	Anesthesiology	Class 2	868.2200	2023-03-13
LDD	Dc-Defibrillator, Low-Energy, (Including Paddles)	Cardiovascular	Class 2	870.5300	2023-05-31
SCN	Temporarily Implanted Peripheral Nerve Stimulation System For Sustained Pain Relief	Neurology	Class 2	882.5870	2026-05-08

Official Correspondent

MARK SCHARNBERG

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

KATECHO LLC

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
K873418	Bodylog, Inc.	BODYLOG STRESS REDUCTION PACKAGE	1987-12-17
K792659	Bio-Feedback Systems, Inc.	FEEDBACK EDR SYSTEM MODEL ME-1	1980-01-09
K030403	Cefar Medical AB	CEFAR REHAB 2 AND REHAB 2 PRO	2003-07-17
K231440	Shenzhen Roundwhale Technology Co. , Ltd.	Combo Electrotherapy Device	2023-11-03
K820884	Nitron Electronics	ELECTRICAL MUSCLE STIMULATOR	1982-04-29

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-2010	Philips Healthcare Inc.	3	HeartStart MRx (M3535A/M3536A) Defibrillator/Monitor. The HeartStart MRx/MRxE is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.
Z-0004-06	Medtronic Emergency Response Systems, Inc.	3	Hard shell carry case for the LIFEPAK 500 AED.
Z-0004-2017	Leonhard Lang Medizintechnik GmbH Archenweg 56 Innsbruck Austria	3	Skintact Electrodes for Defibrillation, DF29N. Product Usage: Multifunction electrode for external defibrillation, pacing, cardioversion, and monitoring. The device is non-sterile and for single use only.
Z-0005-06	Medtronic Emergency Response Systems, Inc.	3	Hard shell carry case for the LIFEPAK CR Plus.
Z-0011-2013	Philips Healthcare Inc.	3	Philips HeartStart XL M4735A Defibrillator/Monitors, used with the M3516A batteries The Heart Start XL Defibrillator/Monitor is a fully featured, defibrillator intended for use by qualified medical personnel, trained in either Advanced Cardiac Life Support or in the operation of the device, in a hospital environment.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1930027. Last updated year: 2026. Please use registration number 1930027 when referencing this establishment in official correspondence.