Data / Medical devices / United States / Vale Medical LLC
Vale Medical LLC: FDA-registered device maker in Midvale, UT, United States, 3 510(k) clearances
Vale Medical LLC is registered with the FDA (registration 3019356418) in Midvale, UT, United States. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated May 3, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3019356418
- Address
- 7231 S. 900 East Suite 200, Midvale, UT, United States, 84047
- Owner or operator
- Vale Medical LLC (10081900)
- Roles
- Complaint file establishment
- First device listed
- July 5, 2023
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Massager, Therapeutic, Electric | ISA | 1 | Complaint file establishment | accessdata.fda.gov |
| Stimulator, Muscle, Powered | IPF | 2 | Complaint file establishment | accessdata.fda.gov |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | 2 | Complaint file establishment | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | 2 | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 3, 2021 | K203710 | Storz Medical MAGNETOLITH Muscle Stimulator | IPF | Substantially Equivalent | Storz Medical AG | accessdata.fda.gov |
| April 13, 2018 | K173692 | D-Actor 200 Vibration Massage System | ISA | Substantially Equivalent | Storz Medical AG | accessdata.fda.gov |
| January 18, 2017 | K161091 | STIMPOD NMS460 Nerve Stimulator | GZJ | Substantially Equivalent | Xavant Technology (Pty), Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Nerve, Transcutaneous, For Pain Relief
- All makers of Stimulator, Muscle, Powered
- All makers of Stimulator, Muscle, Powered, For Muscle Conditioning
- All makers of Massager, Therapeutic, Electric
Updated May 3, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.