Revi™ Wearable Device
GUDID 07290017912028
The Revi Wearable Device wirelessly powers the Revi Implant and enables control of stimulation parameters.
BLUEWIND MEDICAL LTD
Tibial nerve implantable incontinence-control electrical stimulation system| Primary Device ID | 07290017912028 |
| NIH Device Record Key | e3a57457-5b85-45b7-9cfd-17888178e70e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Revi™ Wearable Device |
| Version Model Number | MA-1004-0500 |
| Company DUNS | 534159913 |
| Company Name | BLUEWIND MEDICAL LTD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290017912028 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- deNovo: DEN220073
FDA Product Code
| QXM | Implanted Tibial Electrical Urinary Continence Device |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-25 |
| Device Publish Date | 2023-09-15 |
Devices Manufactured by BLUEWIND MEDICAL LTD
| 07290017912011 - Revi™ Implant | 2023-09-25 Implantable, wireless, battery-less neurostimulation component of the Revi Peripheral Nerve Stimulation System |
| 07290017912028 - Revi™ Wearable Device | 2023-09-25The Revi Wearable Device wirelessly powers the Revi Implant and enables control of stimulation parameters. |
| 07290017912028 - Revi™ Wearable Device | 2023-09-25 The Revi Wearable Device wirelessly powers the Revi Implant and enables control of stimulation parameters. |
| 07290017912035 - Revi™ Clinician Programmer | 2023-09-25 The Revi Clinician Programmer is an application that is the Revi system's interface. |
| 07290017912226 - Revi™ System Patient Kit | 2023-09-25 Revi System Patient Kit intended for patient use containing device components to support therapy. |
| 07290017912332 - Revi™ System Physician Kit | 2023-09-25 Revi™ System Physician Kit is intended to provide physicians necessary device system components to support therapy. |
Trademark Results [Revi]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 REVI 97758165 not registered Live/Pending |
BLUEWIND MEDICAL INC. 2023-01-17 |
 REVI 97146648 not registered Live/Pending |
Eatumup Lure Comapny ,INC. 2021-11-29 |
 REVI 90466883 not registered Live/Pending |
Tay's Sales & Distribution LLC 2021-01-14 |
 REVI 90298583 not registered Live/Pending |
ZYRL Co. 2020-11-04 |
 REVI 90298572 not registered Live/Pending |
ZYRL Co. 2020-11-04 |
 REVI 90278129 not registered Live/Pending |
AIGOU BRAND LIMITED 2020-10-26 |
 REVI 90179100 not registered Live/Pending |
Revi LLC 2020-09-14 |
 REVI 88445211 not registered Live/Pending |
AMQ Solutions, LLC 2019-05-24 |
 REVI 85695586 4424031 Live/Registered |
ReviMedia, Inc. 2012-08-05 |
 REVI 79247712 5823923 Live/Registered |
GRUPO GREMVI GALICIA, S.L. 2018-09-11 |
 REVI 74591734 2057861 Dead/Cancelled |
RECREATIONAL ELECTRIC VEHICLES INT. LLC 1994-10-28 |
 REVI 73808079 1625005 Live/Registered |
EATUMUP LURE COMPANY, INC. 1989-06-21 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.