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Sign in to claim this brandAXELGAARD MANUFACTURING CO., LTD.
United States·US-MF-000009382
Last updated May 24, 2026
What AXELGAARD MANUFACTURING CO., LTD. makes
AXELGAARD MANUFACTURING CO., LTD. produces transcutaneous electrical stimulation electrodes, including single-use and reusable variants for medical applications. Their portfolio also includes drug-delivery iontophoresis patches, designed for targeted transdermal treatment. Examples include foam and cloth electrodes like ValuTrode Lite and UltraStim Pad, as well as reusable systems such as the EconoStim and Ionto480 Buffered Iontophoresis Electrode Treatment Kit.
The company’s devices are classified under Class I and Class II regulations, with listings in the EU’s EUDAMED database and the FDA’s Unique Device Identifier (UDI) system. Their products are manufactured in the United States, adhering to applicable regulatory standards for medical electrical and transdermal devices.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Axelgaard Manufacturing Co., Ltd. primarily manufacture?
Axelgaard Manufacturing Co., Ltd. specializes in transcutaneous electrical stimulation electrodes, including both single-use and reusable versions. Their product line also includes drug-delivery iontophoresis patches, which are designed to facilitate targeted transdermal treatments. Examples include foam and cloth electrodes like ValuTrode Lite and UltraStim Pad, as well as reusable systems such as the EconoStim and Ionto480 Buffered Iontophoresis Electrode Treatment Kit.
Where is Axelgaard Manufacturing Co., Ltd. based, and where are their devices manufactured?
Axelgaard Manufacturing Co., Ltd. is based in the United States. Their devices are manufactured domestically, ensuring compliance with applicable U.S. regulatory standards for medical electrical and transdermal devices.
Which regulatory registries list Axelgaard Manufacturing Co., Ltd.’s devices?
Axelgaard Manufacturing Co., Ltd.’s devices are listed in the EU’s EUDAMED database and the FDA’s Unique Device Identifier (UDI) system. These registries help track and identify their products under applicable regulatory frameworks.
How are Axelgaard Manufacturing Co., Ltd.’s devices classified under medical device regulations?
Axelgaard Manufacturing Co., Ltd.’s devices fall under Class I and Class II classifications. The classification determines the regulatory controls applied to ensure safety and performance, with Class II typically requiring additional scrutiny due to moderate risk.
Why are some of Axelgaard’s devices reusable while others are single-use?
Axelgaard offers both reusable and single-use electrodes to cater to different clinical needs and operational preferences. Reusable devices like the EconoStim are designed for cost efficiency in settings where sterilization and repeated use are feasible, while single-use electrodes like ValuTrode Lite ensure hygiene and reduce cross-contamination risks in environments where disposability is preferred.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 520, Industrial Way, Fallbrook, United States
- Website
- www.axelgaard.com
- —
- —
- [email protected]
- Phone
- 17604518000
- PRRC Contact
- Katherine Klem
- EUDAMED SRN
- US-MF-000009382
- FDA FEI Number
- —
- DUNS Number
- 150959401
Catalogue (140)
Page 1 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ValuTrode Lite Foam | VLF4545 | FDA UDI | Class II | Active |
| ValuTrode Tan Cloth | CT1250 | FDA UDI | Class II | Active |
| ValuTrode Lite Blue Cloth | VL4595 | FDA UDI | Class II | Active |
| EconoStim | ESB50100 | FDA UDI | Class II | Active |
| Pals | PR100 | FDA UDI | Class II | Unknown |
| UltraStim X Derma | USXD2020 | FDA UDI | Class II | Unknown |
| Ionto480 Buffered Iontophoresis Electrode Treatment Kit | Ionto480 DDS275 | FDA UDI | Class II | Active |
| UltraStim X Blue | USXPB5010 | FDA UDI | Class II | Unknown |
| UltraStim Pad | US2040 | FDA UDI | Class II | Active |
| Pals | SC100 | FDA UDI | Class II | Unknown |
| UltraStim X Blue | USXPB5050 | FDA UDI | Class II | Unknown |
| EconoStim | ESB5000 | FDA UDI | Class II | Active |
| UltraStim X Derma | USXD2040 | FDA UDI | Class II | Unknown |
| Little PALS | SEN1003 | FDA UDI | Class II | Unknown |
| UltraStim X | USX2040-4 | FDA UDI | Class II | Unknown |
| Little PALS | SEN2001 | FDA UDI | Class II | Unknown |
| Little PALS | SEN2002 | FDA UDI | Class II | Unknown |
| Pals | COM200 | FDA UDI | Class II | Active |
| UltraStim Pad | US3535 | FDA UDI | Class II | Unknown |
| EconoStim | ESB3050 | FDA UDI | Class II | Unknown |
| UltraStim Pad | US2000 | FDA UDI | Class II | Active |
| ValuTrode Lite White Cloth | VLW4595 | FDA UDI | Class II | Active |
| UltraStim X Foam | USXF200 | FDA UDI | Class II | Active |
| Ionto480 Buffered Iontophoresis Electrode Treatment Kit | Ionto480 DDM325 | FDA UDI | Class II | Active |
| EconoStim | ESB5050 | FDA UDI | Class II | Active |
| PALS Blue | 901220 | FDA UDI | Class II | Active |
| ValuTrode | 180-0040-00 | FDA UDI | Class II | Unknown |
| ValuTrode Lite Tan Cloth | VLT4545 | FDA UDI | Class II | Unknown |
| PALS Blue | 901240 | FDA UDI | Class II | Active |
| ValuTrode Lite Blue Cloth | VL4500 | FDA UDI | Class II | Unknown |
| ValuTrode Lite Tan Cloth | VLT4595 | FDA UDI | Class II | Unknown |
| ValuTrode Lite White Cloth | VLW4545 | FDA UDI | Class II | Active |
| UltraStim X Foam | USXF204 | FDA UDI | Class II | Active |
| ValuTrode Cloth | CF3050 | FDA UDI | Class II | Unknown |
| Ionto480 Buffered Iontophoresis Electrode Treatment Kit | Ionto480 DDL350 | FDA UDI | Class II | Active |
| StimTrode | ST5010 | FDA UDI | Class II | Active |
| ValuTrode Lite Foam | VLF4595 | FDA UDI | Class II | Active |
| UltraStim X Blue | USXPB5000 | FDA UDI | Class II | Active |
| UltraStim X Foam | USXF202 | FDA UDI | Class II | Active |
| Little PALS | SEN4001 | FDA UDI | Class II | Active |
| Pals | 891100 | FDA UDI | Class II | Active |
| Ionto480 Buffered Iontophoresis Electrode Treatment Kit | Ionto480 DDB375 | FDA UDI | Class II | Active |
| Flex-Tone | FT660 | FDA UDI | Class II | Unknown |
| StimTrode | ST4065 | FDA UDI | Class II | Active |
| ValuTrode Lite Blue Cloth | VL4545 | FDA UDI | Class II | Active |
| Pals | 895240 | EUDAMEDFDA UDI | Class I | Active |
| ValuTrode | CF5010 | EUDAMEDFDA UDI | Class I | Active |
| UltraStim Dual | ULB355 | EUDAMEDFDA UDI | Class I | Active |
| UltraStim Snap | SN2020 | EUDAMEDFDA UDI | Class I | Active |
| ValuTrode | CF5000 | EUDAMEDFDA UDI | Class I | Active |
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