Sonolith I-Move Standard Module
The Sonolith i-move module fragments stones in the kidney and ureter using extracorporeal shock wave lithotripsy. It delivers focused pressure pulses to the stone from outside the body.…
The Sonolith i-move module fragments stones in the kidney and ureter using extracorporeal shock wave lithotripsy. It delivers focused pressure pulses to the stone from outside the body. Pulse delivery can use a fixed frequency or be synchronized to the patient.
An electrical discharge generates a shock wave within an ellipsoidal reflector. The reflector concentrates the wave at the treatment focus. A membrane on the generator provides acoustic coupling to the patient’s skin, while a pressure control system regulates operation.
Listed Item
SONOLITH® i-move medical device is a lithotripter of ESWL type (Extracorporeal Shock Wave Lithotripsy). The physical principle consists in delivering pulsed pressure waves which are focalized on the stone to be treated, at fixed frequency or patient synchronized frequency.
Required Setup
The module must be coupled with a table suitable for lithotripsy and at least one imaging system, using ultrasound or an X-ray C-arm. Its stone-fragmentation indication covers the renal pelvis and calyces and the upper, middle and lower ureter.
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Wikkon Precision Technologies Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 1 |
Record
| Listed by | Edap TMS France SA, France |
|---|---|
| FDA product code | LNS |
| Device type | Lithotriptor, Extracorporeal Shock-Wave, Urological |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5990 |
| Establishment | Remanufacturer, Private-label distributor, Complaint-file establishment, Manufacturer |
| 510(k) | K111808 |
| Record published | 2016-09-21 |
| Record revised | 2024-12-11 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2024-05-24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TMS 239269 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Piezolith 3000 Triple-Focus Lithotripsy System Complete | United Medical Systems (DE), Inc. | 47 |
| Piezolith 3000 Triple-Focus Lithotripsy System Complete | United Service Solutions, LLC | 46 |
| Modulith® | Storz Medical AG | 8 |
| Dornier MedTech | Dornier Medtech Gmbh | 6 |
| Econolith EM1000 | Medispec, Ltd. | 5 |
| Econolith E3000 | Medispec, Ltd. | 2 |
| Dornier Delta III | Dornier Medtech Gmbh | 2 |
| Piezolith | Richard Wolf Gmbh | 2 |
| Compact Duet | Direx Systems Corp. | 1 |
| ASADAL-M1 | Huons Co., Ltd. | 1 |
| Econolith E2000 | Medispec, Ltd. | 1 |
| Modularis Variostar | Siemens Healthcare Limited | 1 |
Showing 12 of 20. All products under Lithotriptor, Extracorporeal Shock-Wave, Urological
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K111808 | 2011-08-01 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P870018 | 1999-04-30 | LITHOSTAR MULTILINE | Siemens Healthcare Limited |
| P970019 | 1998-07-14 | HEALTHTRONICS LITHOTRON LIHTOTRIPSY SYSTEM | Healthtronics Surgical Services, Inc. |
| P970062 | 1998-06-24 | GENESTONE 190 LITHOTRIPTER | Bmt, Inc. |
| P950043 | 1998-05-21 | ECONOLITH(TM) LITHOTRIPTER | Medispec, Ltd. |
| P870015 | 1998-03-05 | MEDSTONE STS(TM) LITHOTRIPTER | Medstone Intl., Inc. |
| P920034 | 1997-03-26 | TRIPTER-X1 SERIES SHOCKWAVE LITHOTRIPTERS | Medirex, Inc. |
| P920051 | 1996-06-21 | STORZ MODULITH LITHOTRIPTER, MODEL SLX | Karl Storz Endoscopy-America, Inc. |
| P840008 | 1995-10-05 | DORNIER LITHOTRIPTER TRANSPORTABLE (DLT) | Dornier Medtech America, Inc. |
| P890066 | 1994-04-18 | THERASONIC LITHOTRIPSY TREATMENT SYSTEM | Focus Surgery, Inc. |
| P880042 | 1994-04-18 | EDAP LT.01 SHOCK WAVE LITHOTRIPTER | Edap International Corp. |
| P880011 | 1992-02-10 | TECHNOMED INTERNATIONAL SONOLITH 3000 (LITHORAY)TM | Edap International Corp. |
| P890013 | 1991-09-09 | RICHARD WOLF PIEZOLITH E.L.P. LITHOTRIPT MODEL2300 | Richard Wolf Medical Instruments Corp. |
| P870011 | 1990-09-06 | HMT SHOCK PLUG/LITHOTRIPTER ELECTRODE | Towers Perrin |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.