Axelgaard Mfg. Co., Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 11
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K132422 | PALS PLATINUM NEUROSTIMULATION ELECTRODES | February 13, 2014 |
| K130987 | VALUTRODE NEUROSTIMLATION ELECTRODES | July 17, 2013 |
| K080580 | COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MODEL SMALL DDS275, ME | June 18, 2008 |
| K013532 | ULTRASTIM KIT | August 22, 2002 |
| K000947 | ULTRASTIM ELECTRODE, MODEL US4040 | June 16, 2000 |
| K000206 | PALS NEONATAL PEDIATRIC ECG ELECTRODE, MODELS PN100, PN200 | April 13, 2000 |
| K983741 | EVERLAST NEUROSTIMULATION ELECTRODES 2X 2,MODEL # EL2020 | December 18, 1998 |
| K970426 | VALUETRODE | May 9, 1997 |
| K874469 | TRANSCUTANEOUS ELECTRIC NERVE STIMULATION (TENS) | January 28, 1988 |
| K872976 | TENS PALS PLUS | September 22, 1987 |
| K852267 | ELECTRICAL NERVE STIMULATION(TENS) ELECTRODES | June 18, 1985 |