Question 1

What types of medical devices does Axelgaard Manufacturing Co., Ltd. primarily manufacture?

Accepted Answer

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.

Question 2

Where is Axelgaard Manufacturing Co., Ltd. based, and where are their devices manufactured?

Accepted Answer

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.

Question 3

Which regulatory registries list Axelgaard Manufacturing Co., Ltd.’s devices?

Accepted Answer

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.

Question 4

How are Axelgaard Manufacturing Co., Ltd.’s devices classified under medical device regulations?

Accepted Answer

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.

Question 5

Why are some of Axelgaard’s devices reusable while others are single-use?

Accepted Answer

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.

Device	Model / Reference	Registries	Class	Status
Pals	975220	EUDAMEDFDA UDI	Class I	Active
UltraStim Wire	UF2000	EUDAMEDFDA UDI	Class I	Active
Pals	879200	EUDAMEDFDA UDI	Class I	Active
ValuTrode	CF7515	EUDAMEDFDA UDI	Class I	Active
ValuTrode	VTXF50100	EUDAMEDFDA UDI	Class I	Active
ValuTrode	VTXT505	EUDAMEDFDA UDI	Class I	Active
Pals	975200	EUDAMEDFDA UDI	Class I	Active
PALS StimTrode	ST5090	EUDAMEDFDA UDI	Class I	Active
ValuTrode	CT2020	EUDAMEDFDA UDI	Class I	Active
ValuTrode	CT1535	EUDAMEDFDA UDI	Class I	Active
ValuTrode	CF4065	EUDAMEDFDA UDI	Class I	Active
ValuTrode X	VTX5050	EUDAMEDFDA UDI	Class I	Active
PALS StimTrode	ST32D	EUDAMEDFDA UDI	Class I	Active
ValuTrode	CFF305	EUDAMEDFDA UDI	Class I	Active
Little PALS	SEN 3001	EUDAMEDFDA UDI	Class I	Active
UltraStim Snap Blue	SNB5050	EUDAMED	Class I	Active
PALS StimTrode	ST50D	EUDAMEDFDA UDI	Class I	Active
ValuTrode	CFF203	EUDAMEDFDA UDI	Class I	Active
Pals	976240	EUDAMEDFDA UDI	Class I	Active
ValuTrode	VTX2000	EUDAMEDFDA UDI	Class I	Active
ValuTrode	CT3050	EUDAMEDFDA UDI	Class I	Active
Pals	896230	EUDAMEDFDA UDI	Class I	Active
ValuTrode	CF7000	EUDAMEDFDA UDI	Class I	Active
Pals	J10R00	EUDAMEDFDA UDI	Class I	Active
UltraStim X Blue	USXB5050	EUDAMEDFDA UDI	Class I	Active
Pals	895250	EUDAMEDFDA UDI	Class I	Active
UltraStim	B22-L	EUDAMEDFDA UDI	Class I	Active
Pals	879100	EUDAMEDFDA UDI	Class I	Active
ValuTrode	CFF200	EUDAMEDFDA UDI	Class I	Active
ValuTrode	CF1020	EUDAMEDFDA UDI	Class I	Active
ValuTrode	CT2000	EUDAMEDFDA UDI	Class I	Active
UltraStim Wire	UF2750	EUDAMEDFDA UDI	Class I	Active
UltraStim X	USX2000	EUDAMEDFDA UDI	Class I	Active
UltraStim Pad	US2020	EUDAMEDFDA UDI	Class I	Active
UltraStim Snap	SNC2020	EUDAMED	Class I	Active
UltraStim Snap	SNC2040	EUDAMEDFDA UDI	Class I	Active
Pals X	PX2040	EUDAMEDFDA UDI	Class I	Active
ValuTrode	CT1525	EUDAMEDFDA UDI	Class I	Active
Pals	891200	EUDAMEDFDA UDI	Class I	Active
Pals	976350	EUDAMEDFDA UDI	Class I	Active
ValuTrode	VTXT500	EUDAMEDFDA UDI	Class I	Active
ValuTrode	CFF152	EUDAMEDFDA UDI	Class I	Active
Pals	895220	EUDAMEDFDA UDI	Class I	Active
UltraStim	UF2040	EUDAMEDFDA UDI	Class I	Active
UltraStim	B22-s	EUDAMEDFDA UDI	Class I	Active
PALS StimTrode	ST5050	EUDAMEDFDA UDI	Class I	Active
ValuTrode	CF5050	EUDAMEDFDA UDI	Class I	Active
ValuTrode	CFF202	EUDAMEDFDA UDI	Class I	Active
UltraStim Snap	SN2040	EUDAMEDFDA UDI	Class I	Active
ValuTrode	CF4090	EUDAMEDFDA UDI	Class I	Active

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