# Axelgaard Mfg. Co., Ltd.

- Location (FDA's records): Fallbrook, CA
- FDA decisions: 11 (1985–2014): 11 510(k) clearances
- Product codes: GXY (8), DRX (1), EGJ (1), GZJ (1)
- Predicates its devices cite: 7 (3 its own); citations of its devices by later devices: 23 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Everyway Medical Instruments Co.,Ltd: 2 (https://510kreport.com/company/everyway-medical-instruments)
- North Coast Medical, Inc.: 1 (https://510kreport.com/company/north-coast-medical)
- Dynatronics Corp.: 1 (https://510kreport.com/company/dynatronics)

## Firms that cite its devices most
- Rs Medical: 2 (https://510kreport.com/company/rs-medical)
- Leonhard Lang GmbH: 2 (https://510kreport.com/company/leonhard-lang)
- Compex Technologies, Inc.: 2 (https://510kreport.com/company/compex-technologies)
- Philips Consumer Lifestyle B.V.: 1 (https://510kreport.com/company/philips-consumer-lifestyle)
- Gmdasz Manufacturing Co., Ltd.: 1 (https://510kreport.com/company/gmdasz-manufacturing)
- Prizm Medical, Inc.: 1 (https://510kreport.com/company/prizm-medical)
- Naimco, Inc.: 1 (https://510kreport.com/company/naimco)
- Ampcare, LLC: 1 (https://510kreport.com/company/ampcare)

## Its most-cited devices
- K970426: Valuetrode (1997), cited by 6
- K000206: Pals Neonatal Pediatric Ecg Electrode, Models PN100, PN200 (2000), cited by 4
- K130987: Valutrode Neurostimlation Electrodes (2013), cited by 4
- K013532: Ultrastim Kit (2002), cited by 3
- K000947: Ultrastim Electrode, Model US4040 (2000), cited by 3
- K872976: Tens Pals Plus (1987), cited by 1

## Recent decisions
- K132422: Pals Platinum Neurostimulation Electrodes (Feb 13, 2014)
- K130987: Valutrode Neurostimlation Electrodes (Jul 17, 2013)
- K080580: Comfort Iontophoresis Electrodes/ Buffered Iontophoresis Electrode Treatment, Model Small DDS275, Medium DDM325, Large D (Jun 18, 2008)
- K013532: Ultrastim Kit (Aug 22, 2002)
- K000947: Ultrastim Electrode, Model US4040 (Jun 16, 2000)
- K000206: Pals Neonatal Pediatric Ecg Electrode, Models PN100, PN200 (Apr 13, 2000)
- K983741: Everlast Neurostimulation Electrodes 2X 2,Model # EL2020 (Dec 18, 1998)
- K970426: Valuetrode (May 9, 1997)

Source page: https://510kreport.com/company/axelgaard-mfg