FDA.reportPublic FDA data

Zida

Primary DI
07297539080174
Brand
Zida
Company
EXODUS INNOVATION LTD
Model
Control Sock Black Small
Catalog number
8017
Device description
Zida Control Sock Kit
Published
2022-03-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NAMStimulator, Peripheral Nerve, Non-Implanted, For Pelvic Floor Dysfunction

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192731000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192731000ZIDA Wearable Neuromodulation SystemExodus Innovations2021-03-19NAM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07297539080174PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07297539080174072975390801747297539080174

GMDN Terms#

Term, Definition table
TermDefinition
Sacral plexus implantable incontinence-control electrical stimulation systemAn assembly of battery-powered devices intended to treat urinary and/or faecal incontinence through the application of electrical stimuli to the muscles and/or neural tissue of the pelvic floor/bladder. It consists of an electrode implanted on or in the vicinity of the sacral plexus, a pulse generator with a receiver typically implanted in the abdomen/pelvic region, and an external programmer/transmitter that communicates with the implanted receiver.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(703) 466-0259isaac@livezida.com

Regulatory Flags#

DUNS number
533132825
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07297539014728ZidaZida Control Device14722022-05-05
07297539070175ZidaSock Only, Zida Control Sock Black Small70172022-05-05
07297539072155ZidaSock Only, Zida Control Sock Black Large72152022-05-05
07297539073145ZidaSock Only, Zida Control Sock Black Extra Large73142022-05-05
07297539074135ZidaSock Only, Zida Control Sock White Small74132022-05-05
07297539075125ZidaSock Only, Zida Control Sock White Medium75122022-05-05
07297539076115ZidaSock Only, Zida Control Sock White Large76112022-05-05
07297539077105ZidaSock Only, Zida Control Sock White Extra Large77102022-05-05
07297539071165ZidaSock Only, Zida Control Sock Black Medium71162022-05-04
07297539081164ZidaControl Sock Black Medium81162022-03-03
07297539014711ZidaControl Sock47112022-02-18
07297539082154ZidaControl Sock Black Large82152022-03-03
07297539083144ZidaControl Sock Black Extra Large83142022-03-03
07297539084134ZidaControl Sock White Small84132022-03-03
07297539085124ZidaControl Sock White Medium85122022-03-04
07297539086114ZidaControl Sock White Large86112022-03-03
07297539087104ZidaControl Sock White Extra Large87102022-03-03
07297539008512ZidaControl Sock White Medium2022-03-04
07297539008017ZidaControl Sock Black Small2022-03-03
07297539008116ZidaControl Sock Black Medium2022-03-03

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
00860009634053VivallyAvation 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
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