Bluewind Medical, Inc.

FDA Device Registration & Listing · Salt Lake City, UT, US · Registration 3038988751

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3038988751
FEI Number
3038988751
Entity Name
Bluewind Medical, Inc.
City/State/Country
Salt Lake City, UT, US
Establishment Address
250 E 200 S Ste 1600, Salt Lake City, UT 84111, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
BlueWind Medical Ltd. (Owner Number: 10088572)
Owner / Operator Contact Address
250 E 200 S, Site 1600, Salt Lake City, UT 84111, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K252391
PMA Number
N/A

All Registered Proprietary Names

Revi System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QXM Implanted Tibial Electrical Urinary Continence Device Gastroenterology, Urology Class 2 876.5305 2026-01-07

Official Correspondent

Angel Estrada

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BlueWind Medical Ltd.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3012239564 BLUEWIND MEDICAL LTD. Herzliya Tel Aviv, IL

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038988751. Last updated year: 2026. Please use registration number 3038988751 when referencing this establishment in official correspondence.
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