FDA.reportPublic FDA data

InWave

Primary DI
00852670007052
Brand
InWave
Company
ZYNEX MEDICAL, INC.
Model
400410
Device description
Electrotherapy device for treatment of urinary incontinence.
Published
2021-01-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KPIStimulator, Electrical, Non-Implantable, For Incontinence

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121820000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121820000INWAVEZynex Medical, Inc.2012-08-24KPI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852670007052PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852670007052008526700070528526700070520852670007052

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous incontinence-control electrical stimulatorA device or device assembly available for use by a patient/layperson outside a clinical setting (e.g., in the home) designed to treat urinary and/or faecal incontinence through the transcutaneous (noninvasive) application of electrical stimuli to the muscles of the pelvic floor to induce Kegel-like contractions. It consists of an electrically-powered external pulse generator/biofeedback unit with controls (e.g., wearable remote control) intended for wired or wireless connection to a skin gel pad with surface electrodes designed to be placed on the pubic area; the gel pad may be included in the device assembly. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8004956670customersupport@zynex.com

Regulatory Flags#

DUNS number
141582226
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852670007540M-Wave7012002024-03-18
00852670007045E-Wave7002402023-06-07
00852670007007NexWave4004002021-01-28
00852670007038NeuroMove4002752021-01-28
00852670007151CM-1500 Wrist Cuff7004602021-01-28
00852670007076Zynex Medical Electrodes3000272018-10-01
00852670007083Zynex Medical Electrodes3000382018-10-01
00852670007090Zynex Medical Electrodes3001172018-10-01
00852670007106Zynex Medical Electrodes1230192018-10-01
00852670007113Zynex Medical Electrodes1230182018-10-01
00852670007021TruWave TENS4004202021-01-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06942808259034Intrelief PFEEasyMed Instruments Co., Ltd.KPI2026-05-05
04719872333104LevinaZMI ELECTRONICS LTD.KPI2026-04-14
04719872333593LevinaZMI ELECTRONICS LTD.KPI2026-04-14
04719872333616LevinaZMI ELECTRONICS LTD.KPI2026-04-14
04719872334033LevinaZMI ELECTRONICS LTD.KPI2026-04-14
03830054238138QuantumStar, StarFormerFOTONA d.o.o.KPI2025-06-12
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
06970935830673KONMEDShenzhen Konmed Technology Co., Ltd.KPI2024-03-05
06970935830680KONMEDShenzhen Konmed Technology Co., Ltd.KPI2024-03-05
06970935830697KONMEDShenzhen Konmed Technology Co., Ltd.KPI2024-03-05
05033435135646TensCareTENSCARE LIMITEDKPI2023-10-24
04053815076711MFG-05Zimmer MedizinSysteme GmbHKPI2023-10-16
00860000860000Yarlap IRelevium Labs, Inc.KPI2023-10-07
00860000860031Yarlap IIRelevium Labs, Inc.KPI2023-10-07
05033435070039TensCareTENSCARE LIMITEDKPI2023-08-31
04719871189108iSTIMEVERYWAY MEDICAL INSTRUMENTS CO., LTD.KPI2023-08-30
04719871184769LifecareEVERYWAY MEDICAL INSTRUMENTS CO., LTD.KPI2023-08-25
04719871184776LifecareEVERYWAY MEDICAL INSTRUMENTS CO., LTD.KPI2023-08-25
04719871184783LifecareEVERYWAY MEDICAL INSTRUMENTS CO., LTD.KPI2023-08-25
04719871184790LifecareEVERYWAY MEDICAL INSTRUMENTS CO., LTD.KPI2023-08-25