FDA Registration
Active
🇺🇸 United States
STORZ MEDICAL AMERICA, INC.
Reg #: 1061158
·
FEI: 1000511585
·
Expires 2026
Products
9
Proprietary Names
27
Establishment Types
1
Classifications
9
Registration Details
- Registration Name
- STORZ MEDICAL AMERICA, INC.
- Registration Number
- 1061158
- FEI Number
- 1000511585
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 1000 COBB PLACE BLVD, BUILDING 400, SUITE 450
- City
- Kennesaw
- State
- GA
- ZIP
- 30144
- Country
- US
Regulatory Submissions
- 510(k) Number
- K012482
- PMA Number
- P920051
Owner / Operator
- Firm Name
- STORZ MEDICAL AG
- Operator Number
- 9028780
- Address
- LOHSTAMPFESTRASSE 8, --
- City
- TAEGERWILEN
- State
- Thurgau
- Postal Code
- CH-8274
- Country
- CH
- Correspondent
- JOERG - FREIDINGER
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lithotriptor, Extracorporeal Shock-Wave, Urological | LNS | Class 2 | Gastroenterology, Urology | No | 2007-12-10 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2018-04-27 |
| Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers | PZL | Class 2 | General, Plastic Surgery | No | 2021-03-18 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | Class 2 | Physical Medicine | No | 2021-05-04 |
| Stimulator, Muscle, Powered | IPF | Class 2 | Physical Medicine | No | 2021-05-04 |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | Class 2 | Radiology | No | 2021-02-08 |
| Generator, Shock-Wave, For Pain Relief | NBN | Class 3 | Unknown | No | 2016-06-24 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2010-06-29 |
| Vibrator, Therapeutic | IRO | Class 1 | Physical Medicine | No | 2008-04-29 |
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
StorM-Base 2
MODULITH SLK
V-Actor
MX/1000
Establishment Types
Complaint File Establishment per 21 CFR 820.198