PELVITAL USA, INC.

FDA Device Registration & Listing · Eagan, MN, US · Registration 3017230582

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
3017230582
FEI Number
3017230582
Entity Name
PELVITAL USA, INC.
City/State/Country
Eagan, MN, US
Establishment Address
860 Blue Gentian Rd, Suite 200, Eagan, MN 55121, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Pelvital USA, Inc. (Owner Number: 10077256)
Owner / Operator Contact Address
860 Blue Gentian Rd, Suite 200, Eagan, MN 55121, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K200409
PMA Number
N/A

All Registered Proprietary Names

Flyte System MTI-1.5 Flyte

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HIR Perineometer Obstetrics/Gynecology Class 2 884.1425 2024-10-09
HIR Perineometer Obstetrics/Gynecology Class 2 884.1425 2020-08-18

Official Correspondent

Lydia Zeller

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Pelvital USA, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017230582. Last updated year: 2026. Please use registration number 3017230582 when referencing this establishment in official correspondence.
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