Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1061158

FEI Number

1000511585

Entity Name

STORZ MEDICAL AMERICA, INC.

City/State/Country

Kennesaw, GA, US

Establishment Address

1000 COBB PLACE BLVD, BUILDING 400, SUITE 450, Kennesaw, GA 30144, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

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

N/A

PMA Number

P080028

All Registered Proprietary Names

MODULITH SLK with MULTIVIEW option MODULITH SLX-F2 165mm therapy head 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 SLX-F2 180mm therapy head MODULITH SLX-F2 DUOLITH SD1 T-TOP MODULITH SLK with inline ultrasound imaging MAGNETOLITH MODULITH SLX-F2 StorM-Touch XR-MX/1000 MODULITH SL20 MODULITH SLX CHATTANOOGA Intelect F-SW USA DUOLITH SD1 T-Top DUOLITH SD1 TOWER

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
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	2007-12-05
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	2008-07-30
LNS	Lithotriptor, Extracorporeal Shock-Wave, Urological	Gastroenterology, Urology	Class 2	876.5990	2021-04-08
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	2007-12-10
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	2007-12-10
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2021-02-08
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

Official Correspondent

JOERG FREIDINGER

US Agent Details

No US Agent registered (Local establishment).

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
9613347	STORZ MEDICAL AG	TAEGERWILEN Thurgau, CH

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
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
K201958	Therasigma, LLC	ETD Family of Electrotherapy Devices	2020-08-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2007	GE OEC Medical Systems, Inc	2	GE 4 inch Anterior Cervical Post, GE Part Number 1006385 or 1006385-NAV, GE Healthcare OEC Medical Systems (an accessory used with the InstaTrak 3500 plus and 9800 C-Arm Navigation systems)
Z-0001-2009	Philips Medical Systems North America Co. Phillips	2	NeuViz Dual Multi-Slice Computed Tomography (CT) Scanner System (software). Whole body x-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system software is an interactive program used for x-ray scan control, image reconstruction, and image archive/evaluation. It is intended to produce cross-section images of head and body by computer reconstruction of x-ray transmission data taken at different angles. The function of Time Scan is intended to use in contrast scan include single phase and multi-phase scan, that is according to different density of contrast in vessels or organs between different phase to get necessary information to support doctor's diagnosis.
Z-0004-2010	Ge Healthcare	2	GE OEC 9900 Elite ESP To produce mobile fluoroscopic images of human anatomy.
Z-0005-2010	Ge Healthcare	2	GE OEC 9900 Elite GSP Fluoroscopes To produce mobile fluoroscopic images of human anatomy.
Z-0009-04	Siemens Medical Solutions USA, Inc	2	Urology X-Ray System, Uroskop D1/D2/D3 - Hardware for Motor Drive

Similar Registrations

Registration Number	Establishment Name	Location
3029915542	HUONS MEDITECH CO., LTD	Seongnam-si Gyeonggi, KR
3002807616	MEDISPEC, LTD.	YEHUD Central, IL
9613347	STORZ MEDICAL AG	TAEGERWILEN Thurgau, CH
9611388	DORNIER MEDTECH GMBH	WESSLING Bavaria, DE
3017140415	INITIA, LTD.	Petah Tikva Central, IL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1061158. Last updated year: 2026. Please use registration number 1061158 when referencing this establishment in official correspondence.