FDA.reportPublic FDA data

Revi™ Wearable Device

Primary DI
07290017912042
Brand
Revi™ Wearable Device
Company
BLUEWIND MEDICAL LTD
Model
MA-3000-1300
Device description
Revi Wearable Device wirelessly powers the Revi Implant and enables control of stimulation parameters.
Published
2026-01-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QXMImplanted Tibial Electrical Urinary Continence Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QXMImplanted Tibial Electrical Urinary Continence DeviceGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN220073000
K240037000
K252391000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN220073000Revi SystemBluewind Medical , Ltd.2023-08-16QXM
K240037000Revi™ SystemBluewind Medical , Ltd.2024-05-02QXM
K252391000Revi SystemBluewind Medical , Ltd.2025-12-12QXM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290017912042PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290017912042072900179120427290017912042

GMDN Terms#

Term, Definition table
TermDefinition
Tibial nerve 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 sacral plexus via tibial nerve stimulation. It consists of an electrode implanted in the vicinity of the tibial nerve, an external transcutaneous pulse generator attached to the leg, and an external programmer/transmitter that communicates with the pulse generator.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18887152080info@bluewindmedical.com

Regulatory Flags#

DUNS number
534159913
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290017912097Revi™ Implant MA-1007-16002026-01-28
07290017912240Revi™ System Patient KitKA-3000-0001_US_CM2026-01-28
07290017912387Revi™ System Physician KitKA-3000-0002_US_CM2026-01-28
07290017912011Revi™ ImplantMA-1007-0600_US_CM2023-09-15
07290017912028Revi™ Wearable DeviceMA-1004-05002023-09-15
07290017912035Revi™ Clinician ProgrammerDV-9500-0001_US_CM2023-09-15
07290017912226Revi™ System Patient KitKA-9000-0001_US_CM2023-09-15
07290017912332Revi™ System Physician KitKA-9000-0002_US_CM2023-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290017912097Revi™ Implant BLUEWIND MEDICAL LTDQXM2026-01-28
07290017912240Revi™ System Patient KitBLUEWIND MEDICAL LTDQXM2026-01-28
07290017912387Revi™ System Physician KitBLUEWIND MEDICAL LTDQXM2026-01-28
07290017912011Revi™ ImplantBLUEWIND MEDICAL LTDQXM2023-09-15
07290017912028Revi™ Wearable DeviceBLUEWIND MEDICAL LTDQXM2023-09-15
07290017912035Revi™ Clinician ProgrammerBLUEWIND MEDICAL LTDQXM2023-09-15
07290017912226Revi™ System Patient KitBLUEWIND MEDICAL LTDQXM2023-09-15
07290017912332Revi™ System Physician KitBLUEWIND MEDICAL LTDQXM2023-09-15