Data / Medical devices / United States / Axelgaard MFG. Co., Ltd.
Axelgaard MFG. Co., Ltd.: FDA-registered device maker in Fallbrook, CA, United States, 5 510(k) clearances
Axelgaard MFG. Co., Ltd. is registered with the FDA (registration 2025066) in Fallbrook, CA, United States. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated February 13, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2025066
- FEI number
- 1000603528
- Address
- 520 Industrial Way, Fallbrook, CA, United States, 92028
- Owner or operator
- Axelgaard Manufacturing Co. Ltd. (9010494)
- Roles
- Manufacturer
- First device listed
- January 16, 2008
- Registered through
- 2026
- Brand names listed
- Buffered Iontophoresis Electrodes, Comfort Iontophoresis Electrodes /, Little PALS, PALS Neurostimulation Electrodes, UltraStim ELectrode, Model US4040, ValuTrode OTC Neurostimulation Electrodes
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Iontophoresis, Other Uses | EGJ | 2 | Manufacturer | accessdata.fda.gov |
| Electrode, Cutaneous | GXY | 2 | Manufacturer | accessdata.fda.gov |
| Electrode, Electrocardiograph | DRX | 2 | Manufacturer | 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 13, 2014 | K132422 | PALS PLATINUM NEUROSTIMULATION ELECTRODES | GXY | Substantially Equivalent | Axelgaard Mfg. Co., Ltd. | accessdata.fda.gov |
| July 17, 2013 | K130987 | VALUTRODE NEUROSTIMLATION ELECTRODES | GXY | Substantially Equivalent | Axelgaard Mfg. Co., Ltd. | accessdata.fda.gov |
| June 18, 2008 | K080580 | COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MODEL SMALL DDS275, MEDIUM DDM325, LARGE D | EGJ | Substantially Equivalent | Axelgaard Mfg. Co., Ltd. | accessdata.fda.gov |
| June 16, 2000 | K000947 | ULTRASTIM ELECTRODE, MODEL US4040 | GXY | Substantially Equivalent | Axelgaard Mfg. Co., Ltd. | accessdata.fda.gov |
| April 13, 2000 | K000206 | PALS NEONATAL PEDIATRIC ECG ELECTRODE, MODELS PN100, PN200 | DRX | Substantially Equivalent | Axelgaard Mfg. Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrode, Cutaneous
- All makers of Device, Iontophoresis, Other Uses
- All makers of Electrode, Electrocardiograph
Updated February 13, 2014. 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.