Extracorporeal Shock Wave Lithotripter

Basic Information

• Brand Name: Extracorporeal Shock Wave Lithotripter
• Primary DI: 06974928350131
• Version / Model: U200
• Company Name: Shenzhen Wikkon Precision Technologies Co., Ltd.
• Labeler DUNS: 543036260
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-07-30
• Public Version: 1
• Public Version Date: 2025-08-07
• Public Version Status: New
• Public Device Record Key: ff2f496e-c584-4c5a-895b-aac927a64923

Device Description

U200 ESWL system focuses shock waves into the body using ultrasound guidance to fragment urinary calculi (i.e kidney and ureteral stones). U200 system incorporates a shock wave generator, high voltage generator, control console, ultrasound system and patient table. Prior to treatment, the stone is targeted using a stand-alone ultra-sound system. Shock waves are typically generated using electromagnetically repelled membranes. These shock waves are focused onto the stone with specially designed acoustic lens. The shock waves are created under water by the shock wave generator, and are transferred to the patient’s body through a water-filled silicon cushion. Once the stone is fragmented by the focused shock waves, the fragments pass out of the body with the patient’s urine. U200 system is available in stationary configuration, and are indicated for use in a single health care facility

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LNS	Lithotriptor, Extracorporeal Shock-Wave, Urological	Gastroenterology, Urology	876.5990	2

GMDN Terms

Code	Name	Definition	Implantable	Status
18415	Electromechanical lithotripsy system, extracorporeal	An assembly of devices that non-invasively disintegrates stones (i.e., calculi) by sending focused shock waves from outside the body produced by an electromechanical generator. This generator contains a coil attached to a thin metallic membrane; a magnetic field is produced by an electric current conducted through the coil, and shock waves are generated when the metallic membrane is repelled by the magnetic field. The system also includes a treatment table, an imaging system, and an operator's console. This [extracorporeal shock wave lithotripsy (ESWL)] system is used to disintegrate stones located in the kidneys, urinary tract, gallbladder, or bile/pancreatic ducts.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06974928350131	GS1

Premarket Submissions

Submission Number	Supplement Number
K242922	000