VALE MEDICAL LLC

FDA Device Registration & Listing · Midvale, UT, US · Registration 3019356418

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
3019356418
FEI Number
3019356418
Entity Name
VALE MEDICAL LLC
City/State/Country
Midvale, UT, US
Establishment Address
7231 S. 900 East, Suite 200, Midvale, UT 84047, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Vale Medical LLC (Owner Number: 10081900)
Owner / Operator Contact Address
7231 S. 900 East, Suite 200, Midvale, UT 84047, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K161091
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IPF Stimulator, Muscle, Powered Physical Medicine Class 2 890.5850 2023-07-05
NGX Stimulator, Muscle, Powered, For Muscle Conditioning Physical Medicine Class 2 890.5850 2023-07-05
ISA Massager, Therapeutic, Electric Physical Medicine Class 1 890.5660 2023-07-05
GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief Neurology Class 2 882.5890 2023-07-05

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

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

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K030403 Cefar Medical AB CEFAR REHAB 2 AND REHAB 2 PRO 2003-07-17
K231440 Shenzhen Roundwhale Technology Co. , Ltd. Combo Electrotherapy Device 2023-11-03
K820884 Nitron Electronics ELECTRICAL MUSCLE STIMULATOR 1982-04-29
K201958 Therasigma, LLC ETD Family of Electrotherapy Devices 2020-08-04
K964028 Mettler Electronics Corp. SYS STIM 226 1997-02-03

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3019356418. Last updated year: 2026. Please use registration number 3019356418 when referencing this establishment in official correspondence.
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