FDA.reportPublic FDA data

Urostym

Primary DI
00627825006019
Brand
Urostym
Company
Laborie Medical Technologies Canada ULC
Model
PRO180
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HIRPERINEOMETER
KPISTIMULATOR, ELECTRICAL, NON-IMPLANTABLE, FOR INCONTINENCE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIRPerineometerObstetrics/Gynecology2
KPIStimulator, Electrical, Non-Implantable, For IncontinenceGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00627825006019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00627825006019006278250060196278250060190627825006019

GMDN Terms#

Term, Definition table
TermDefinition
Biofeedback systemAn assembly of devices intended to provide visual and/or auditory signals corresponding to the status of one or more of a patient's physiological functions, e.g., brain wave activity, muscle activity, blood pressure, skin temperature, balance, so that the patient can develop some degree of conscious control over a usually involuntarily function. This system will detect changes in the physiological functions that are outside of the normal awareness, amplify these signals, and provide this as feedback to the patient. It is used in, e.g., tension headache control, muscle relaxation, rehabilitation/training, behavioural research.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
203383526
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10627825005958Urocap IV LightUCL10002016-09-21
10627825005965Urocap IV LightUCL10012016-09-21
00627825003599Urocap IVTRA8512016-09-21
00627825003629Urocap VTRA10022016-09-21
00627825005760Urocap IIITRA7092016-09-21
00627825005777Urocap IIITRA7112016-09-21
00627825005937Urocap IV LightUCL20002016-09-21
00627825005944Urocap IV LightUCL20012016-09-21
00627825000031Pump Tubing Infusion LineTUB5002016-09-21
00627825011013Probe, Manometry, Vaginal SensorPRB1132017-09-01
00627825011020Probe, Manometry, Anal SensorPRB1082017-09-01
00627825011037Tube for Anal Sensor, with 3-way StopcockPRB0782017-09-01
00627825011044Tube for Vaginal Sensor, with 3-way StopcockPRB0802017-09-01
00627825000109ITAITA2016-09-21
00627825008204Y-Piece9021P11642016-09-21
10627825007020Extension Set 29021P12832016-09-21
10627825007297Extension Line, 60 cm9021P63122016-09-21
10627825007310Extension Line, 1500mm9021P63322016-09-21
10627825007327Extension Line, 15cm9021P63512016-09-21
10627825007341Extension Line, 150cm Blue9021P63712016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06927394503211K-fitHunan Accurate Bio-Medical Technology Co., Ltd.HIR2026-09-05
00884400438867NATrinity Medical Solutions, LLCKPI2026-08-27
B108398AP1MA3MUS00Chair ApplicatorBTL INDUSTRIES LIMITEDKPI2026-08-27
B108398PO11MUS00EMSELLA DUOBTL INDUSTRIES LIMITEDKPI2026-08-27
06970935830635Pelvic Muscle TrainerShenzhen Konmed Technology Co., Ltd.KPI2026-07-08
06970935830734Pelvic Muscle TrainerShenzhen Konmed Technology Co., Ltd.KPI2026-07-08
00860331002063Flyte SystemPELVITAL USA, INC.HIR2026-07-06
06942808259034Intrelief PFEEasyMed Instruments Co., Ltd.KPI2026-05-05
00864124000137Vaginal Tactile Ultrasound ImagerAdvanced Tactile Imaging, Inc.HIR2026-04-23
04719872333104LevinaZMI ELECTRONICS LTD.KPI2026-04-14
04719872333104LevinaZMI ELECTRONICS LTD.HIR2026-04-14
04719872333593LevinaZMI ELECTRONICS LTD.HIR2026-04-14
04719872333593LevinaZMI ELECTRONICS LTD.KPI2026-04-14
04719872333616LevinaZMI ELECTRONICS LTD.HIR2026-04-14
04719872333616LevinaZMI ELECTRONICS LTD.KPI2026-04-14
04719872334033LevinaZMI ELECTRONICS LTD.KPI2026-04-14
03830054238138QuantumStar, StarFormerFOTONA d.o.o.KPI2025-06-12
00810138370834DeliceBlush NoveltiesHIR2025-03-13
00819835024125WellnessBlush NoveltiesHIR2025-01-28
05033435134403TensCareTENSCARE LIMITEDKPI2024-11-18
G680LT2061Neocontrol Pelvic Floor Therapy System, Incontinence Treatment DeviceBLISSCO MEDICAL DEVICE LIMITEDKPI2024-11-14
LT2061Neocontrol Pelvic Floor Therapy System, Incontinence Treatment DeviceBLISSCO MEDICAL DEVICE LIMITEDKPI2024-11-14
03830054237728StarFormerFOTONA d.o.o.KPI2024-07-30
00092237626047Richmar EMG ProDrive Devilbiss HealthcareKPI2024-06-28
00092237626054Richmar EMG ProDrive Devilbiss HealthcareKPI2024-06-28
06970935830482KONMEDShenzhen Konmed Technology Co., Ltd.KPI2024-03-05
06970935830499KONMEDShenzhen Konmed Technology Co., Ltd.KPI2024-03-05
06970935830642KONMEDShenzhen Konmed Technology Co., Ltd.KPI2024-03-05
06970935830659KONMEDShenzhen Konmed Technology Co., Ltd.KPI2024-03-05
06970935830666KONMEDShenzhen Konmed Technology Co., Ltd.KPI2024-03-05