Data / Medical devices / United States / Axion Usa LLC
Axion Usa LLC: FDA-registered device maker in Carteret, NJ, United States, 5 510(k) clearances
Axion Usa LLC is registered with the FDA (registration 3027329006) in Carteret, NJ, United States. It lists 5 device types. The FDA files 5 510(k) clearances under its listings, the newest dated February 12, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027329006
- Address
- 120 Raskulinecz Rd, Carteret, NJ, United States, 07008
- Owner or operator
- Axion USA (10088047)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- May 18, 2023
- Registered through
- 2026
- Brand names listed
- Axion Kinesiology Band Stim Pro, Axion Stim-Pro Comfort, Axion Stim-Pro I-2000, Axion USA LLC, Pelvic Floor Trainer STIM-PRO I-3000, axion
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrode, Cutaneous | GXY | 2 | Repackager or relabeler | accessdata.fda.gov |
| Media, Electroconductive | GYB | 2 | Repackager or relabeler | accessdata.fda.gov |
| Stimulator, Electrical, Non-Implantable, For Incontinence | KPI | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | 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 12, 2026 | K251760 | Well-Life Incontinence Stimulation System (WL-2405i(P)) | KPI | Substantially Equivalent | Well-Life Healthcare , Ltd. | accessdata.fda.gov |
| December 13, 2022 | K222770 | Conductive Gel | GYB | Substantially Equivalent | Top-Rank Health Care Co., Ltd. | accessdata.fda.gov |
| December 3, 2021 | K213116 | Everyway Incontinence Stimulation System | KPI | Substantially Equivalent | Everyway Medical Instruments Co.,Ltd | accessdata.fda.gov |
| August 11, 2016 | K160138 | Adhesive Electrodes | GXY | Substantially Equivalent | Gmdasz Manufacturing Co., Ltd. | accessdata.fda.gov |
| May 27, 2004 | K040512 | LIMITED FUNCTION WL/OTC-TENS DEVICE, MODEL WL-2103A, WL-2203A, WL-2203B AND WL-2401 | GZJ | Substantially Equivalent | Well-Life Healthcare, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Electrical, Non-Implantable, For Incontinence
- All makers of Stimulator, Nerve, Transcutaneous, For Pain Relief
- All makers of Tape And Bandage, Adhesive
- All makers of Electrode, Cutaneous
- All makers of Media, Electroconductive
Updated February 12, 2026. 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.