FDA.reportPublic FDA data

Zida

Primary DI
07297539008017
Brand
Zida
Company
EXODUS INNOVATION LTD
Model
Control Sock Black Small
Device description
Zida Control Sock Kit
Published
2022-03-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

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
07297539008017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07297539008017072975390080177297539008017

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
07297539080174ZidaControl Sock Black Small80172022-03-03
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
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
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
07297539008116ZidaEXODUS INNOVATION LTDNAM2022-03-03
07297539008215ZidaEXODUS INNOVATION LTDNAM2022-03-03