Data / Medical devices / United States / Nxtstim, LLC
Nxtstim, LLC: FDA-registered device maker in San Diego, CA, United States, 3 510(k) clearances
Nxtstim, LLC is registered with the FDA (registration 3022631685) in San Diego, CA, United States. It lists 6 device types. The FDA files 3 510(k) clearances under its listings, the newest dated February 3, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3022631685
- Address
- 5362 Sweetwater Trail, San Diego, CA, United States, 92130
- Owner or operator
- NXTSTIM, INC (10085260)
- Roles
- Repackager or relabeler
- First device listed
- March 15, 2023
- Registered through
- 2026
- Brand names listed
- EcoAi, EcoMini, Self-adhesive electrode
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrode, Cutaneous | GXY | 2 | Repackager or relabeler | accessdata.fda.gov |
| Stimulator, Muscle, Powered | IPF | 2 | Repackager or relabeler | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | 2 | Repackager or relabeler | accessdata.fda.gov |
| Stimulator, Peripheral Nerve, Implanted (Pain Relief) | GZF | 2 | Repackager or relabeler | accessdata.fda.gov |
| Stimulator, Spinal-Cord, Implanted (Pain Relief) | GZB | 2 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| February 3, 2021 | K192568 | Jiajian Self-Adhesive Electrode | GXY | Substantially Equivalent | Wuxi Jiajian Medical Instrument Co., Ltd. | accessdata.fda.gov |
| August 14, 2020 | K200848 | Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit | GZF | Substantially Equivalent | Micron Medical Corporation | accessdata.fda.gov |
| December 23, 2019 | K192733 | RelieforMe TENS/EMS Device Model UPK-GE01 | IPF | Substantially Equivalent | Umeheal , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Nerve, Transcutaneous, For Pain Relief
- All makers of Stimulator, Nerve, Transcutaneous, Over-The-Counter
- All makers of Stimulator, Muscle, Powered
- All makers of Stimulator, Peripheral Nerve, Implanted (Pain Relief)
- All makers of Stimulator, Spinal-Cord, Implanted (Pain Relief)
- All makers of Electrode, Cutaneous
Updated February 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.