FDA.reportPublic FDA data

Vivally

Primary DI
00860009634053
Brand
Vivally
Company
Avation Medical, Inc.
Model
VCG-SRN01
Published
2024-10-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NAMStimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NAMStimulator, Peripheral Nerve, Non-Implanted, For Urinary IncontinenceGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220454000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220454000Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile ApplicationAvation Medical, Inc.2023-04-03NAM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860009634053PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009634053008600096340538600096340530860009634053

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

Regulatory Flags#

DUNS number
081061890
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850053656026VivallyVCG-KDS012024-10-29
00850053656033VivallyVCG-KDM012024-10-29
00860009634022VivallyVCG-GAM012024-10-29
00860009634039VivallyVCG-GAS012024-10-29
00860009634046VivallyVPG-KTS012023-08-01
00860009634077VivallyVCG-GC3012023-08-01
00860009634084VivallyVCG-GC5012023-08-01
00860009634008VivallyVCG-KTS012023-07-31
00860009634015VivallyVCG-KTM012023-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850053656026VivallyAvation Medical, Inc.NAM2024-10-29
00850053656033VivallyAvation Medical, Inc.NAM2024-10-29
00860009634022VivallyAvation Medical, Inc.NAM2024-10-29
00860009634039VivallyAvation Medical, Inc.NAM2024-10-29
00860009634046VivallyAvation Medical, Inc.NAM2023-08-01
00860009634077VivallyAvation Medical, Inc.NAM2023-08-01
00860009634084VivallyAvation Medical, Inc.NAM2023-08-01
00860009634008VivallyAvation Medical, Inc.NAM2023-07-31
00860009634015VivallyAvation Medical, Inc.NAM2023-07-31
07297539014728ZidaEXODUS INNOVATION LTDNAM2022-05-05
07297539070175ZidaEXODUS INNOVATION LTDNAM2022-05-05
07297539072155ZidaEXODUS INNOVATION LTDNAM2022-05-05
07297539073145ZidaEXODUS INNOVATION LTDNAM2022-05-05
07297539074135ZidaEXODUS INNOVATION LTDNAM2022-05-05
07297539075125ZidaEXODUS INNOVATION LTDNAM2022-05-05
07297539076115ZidaEXODUS INNOVATION LTDNAM2022-05-05
07297539077105ZidaEXODUS INNOVATION LTDNAM2022-05-05
07297539071165ZidaEXODUS INNOVATION LTDNAM2022-05-04
07297539085124ZidaEXODUS INNOVATION LTDNAM2022-03-04
07297539008512ZidaEXODUS INNOVATION LTDNAM2022-03-04
07297539080174ZidaEXODUS INNOVATION LTDNAM2022-03-03
07297539081164ZidaEXODUS INNOVATION LTDNAM2022-03-03
07297539082154ZidaEXODUS INNOVATION LTDNAM2022-03-03
07297539083144ZidaEXODUS INNOVATION LTDNAM2022-03-03
07297539084134ZidaEXODUS INNOVATION LTDNAM2022-03-03
07297539086114ZidaEXODUS INNOVATION LTDNAM2022-03-03
07297539087104ZidaEXODUS INNOVATION LTDNAM2022-03-03
07297539008017ZidaEXODUS INNOVATION LTDNAM2022-03-03
07297539008116ZidaEXODUS INNOVATION LTDNAM2022-03-03
07297539008215ZidaEXODUS INNOVATION LTDNAM2022-03-03