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Extracorporeal Shock Wave Lithotripter

FDA UDI

Class II (US FDA UDI)

by Shenzhen Wikkon Precision Technologies Co., Ltd.

Identity

Trade Name
Extracorporeal Shock Wave Lithotripter FDA UDI
Generic Name
Electromechanical lithotripsy system, extracorporeal FDA UDI
Device Name
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 FDA UDI
Model / Reference
U200 FDA UDI
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 FDA UDI

Identifiers

Primary DI / UDI-DI
06974928350131 FDA UDI
510(k) Number
K242922 FDA UDI
FDA Product Code
LNS FDA UDI
GMDN Term
Electromechanical lithotripsy system, extracorporeal FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5990 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Electromechanical lithotripsy system, extracorporeal

Extracorporeal Shock Wave Lithotripter by Shenzhen Wikkon Precision Technologies Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Electromechanical lithotripsy system, extracorporeal.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Shenzhen Wikkon Precision Technologies Co., Ltd.

Sources (1)

  • FDA UDI ff2f496e-c584-4c5a-895b-aac927a64923 34 fields · synced Jun 1, 2026