Who else makes this device?

Name: Compact Duet
Brand: Compact Duet

Gastroenterology & Urology › TherapeuticLithotriptor, Extracorporeal Shock-Wave, Urological

Compact Duet

The Duet is indicated for use in the fragmentation of urinary tract stones (i.e. renal calyceal, renal pelvic, and upper ureteral stones). The Duet is a transportable Extracorporeal Shock…

Registry build 21.09.26

The Duet is indicated for use in the fragmentation of urinary tract stones (i.e. renal calyceal, renal pelvic, and upper ureteral stones). The Duet is a transportable Extracorporeal Shock Wave Lithotripsy device, which consists of Shock Wave Generator (SWAG), a Motorized Floating Treatment Table (MFT), and Computer Console. The Duet does not provide imaging or monitoring functions, but contain the necessary interfaces for fluoroscopy and ECG R Wave Synchronization. The Duet is small and Transportable and can be used in any room equipped with the proper anesthesia devices. Special electrodes placed within two reflectors generate high-energy sparks, which can be controlled within defined limits. The shock waves generated by the sparks are focused through water and through the body to converge on the calculus. The shock waves must be generated and transmitted through liquid to assure that sufficient energy is delivered to the stone. A series of the focused shock waves is used for the stone disintegration.

1manufacturer

1catalogue number

7510(k) clearances naming this product code

Who Else Makes It

Registered in Guangdong.

Chinese manufacturers registered for FDA product code LNS
Manufacturer	City	Province	Registered as	Device types
Shenzhen Wikkon Precision Technologies Co., Ltd.	Shenzhen	Guangdong	Manufacturer	1

Record

Regulatory record for Compact Duet
Listed by	Direx Systems Corp., United States
FDA product code	LNS
Device type	Lithotriptor, Extracorporeal Shock-Wave, Urological
Device class	Class 2
Regulation	21 CFR 876.5990
Record published	2016-11-02
Record revised	2018-03-29 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Latex	Contains natural rubber latex
Label carries	lot or batch number, manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Compact Duet
Catalogue number	Size	Status
COMPACT DUET		In distribution

Same Product Code

Other products under the same FDA 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
Sonolith i-move Standard Module	Edap TMS France SA	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

FDA 510(k) clearances naming this product code
Clearance	Decision date
K111947	2012-03-01
K062147	2006-10-20
K053640	2006-03-01
K050091	2005-03-16
K041582	2004-07-07
K040470	2004-04-28
K023535	2003-01-17

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.

FDA premarket approvals naming this product code
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.