Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9613347

FEI Number

3002808188

Entity Name

STORZ MEDICAL AG

City/State/Country

TAEGERWILEN Thurgau, CH

Establishment Address

LOHSTAMPFESTRASSE 8, TAEGERWILEN Thurgau 8274, CH

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

STORZ MEDICAL AG (Owner Number: 9028780)

Owner / Operator Contact Address

LOHSTAMPFESTRASSE 8, --, TAEGERWILEN, CH-TG CH-8274, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K040476

PMA Number

N/A

All Registered Proprietary Names

V-Actor MODULITH SLX-F2 StorM-Touch MODULITH SLK with MULTIVIEW option MASTERPULS ONE CHATTANOOGA Mobile 2 RPW USA D-ACTOR 200 D-ACTOR 100 D-ACTOR 50 DUOLITH SD1 R-SW MASTERPULS MP100 MASTERPULS icon MASTERPULS R-SW100 MODULITH SLK MODULITH SLK with inline ultrasound imaging DUOLITH SD1 T-TOP MODULITH SLK MAGNETOLITH MODULITH SLX-F2 180mm therapy head StorM-Base 2 MODULITH SL20 MODULITH SLX CHATTANOOGA Intelect F-SW USA DUOLITH SD1 T-Top DUOLITH SD1 TOWER MODULITH SLX-F2 165mm therapy head

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IRO	Vibrator, Therapeutic	Physical Medicine	Class 1	890.5975	2008-04-29
LNS	Lithotriptor, Extracorporeal Shock-Wave, Urological	Gastroenterology, Urology	Class 2	876.5990	2007-12-10
LNS	Lithotriptor, Extracorporeal Shock-Wave, Urological	Gastroenterology, Urology	Class 2	876.5990	2007-12-10
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2018-04-27
LNS	Lithotriptor, Extracorporeal Shock-Wave, Urological	Gastroenterology, Urology	Class 2	876.5990	2007-12-10
LNS	Lithotriptor, Extracorporeal Shock-Wave, Urological	Gastroenterology, Urology	Class 2	876.5990	2007-12-10
PZL	Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers	General, Plastic Surgery	Class 2	878.4685	2021-03-18
LNS	Lithotriptor, Extracorporeal Shock-Wave, Urological	Gastroenterology, Urology	Class 2	876.5990	2014-08-20
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2021-05-04
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2021-05-04
LNS	Lithotriptor, Extracorporeal Shock-Wave, Urological	Gastroenterology, Urology	Class 2	876.5990	2008-07-30
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2010-06-29
LNS	Lithotriptor, Extracorporeal Shock-Wave, Urological	Gastroenterology, Urology	Class 2	876.5990	2007-12-10
NBN	Generator, Shock-Wave, For Pain Relief	Unknown	Class 3	N/A	2016-06-24
LNS	Lithotriptor, Extracorporeal Shock-Wave, Urological	Gastroenterology, Urology	Class 2	876.5990	2007-12-05

Official Correspondent

No official correspondent registered.

US Agent Details

Cory Alcala Business: STORZ MEDICAL AMERICA INC. Email: cory.alcala@storzmedicalamerica.com Phone: (678) 3456229

Related Public Records

Same Entity

STORZ MEDICAL AG

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1061158	STORZ MEDICAL AMERICA, INC.	Kennesaw, GA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K821133	Durham Electric Co.	ELECTRICAL VIBRATING DEVICE	1982-07-09
K221200	Xbody Hungary Kft.	XBody Go USA, XBody Pro USA	2023-01-31
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-0012-2022	GE Healthcare, LLC	2	Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016	GE Healthcare	2	Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026	CHANGE HEALTHCARE CANADA COMPANY	2	Change Healthcare Radiology Solutions software version 14.2.2
Z-0032-2012	Philips Healthcare Inc.	2	MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
Z-0033-2007	AGFA Corp.	2	IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9613347. Last updated year: 2026. Please use registration number 9613347 when referencing this establishment in official correspondence.