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 Clinical	210240	EUDAMEDFDA UDI	Class I	Active
Pals	975240	EUDAMEDFDA UDI	Class I	Active
ValuTrode	CT2035	EUDAMEDFDA UDI	Class I	Active
UltraStim Snap	SN2040-D	EUDAMEDFDA UDI	Class I	Active
UltraStim	SA1004	EUDAMED	Class I	Active
Pals	895340	EUDAMEDFDA UDI	Class I	Active
ValuTrode	CT2040	EUDAMEDFDA UDI	Class I	Active
UltraStim Dual	ULB250	EUDAMEDFDA UDI	Class I	Active
UltraStim Wire	UF1250	EUDAMEDFDA UDI	Class I	Active
Pals	879300	EUDAMEDFDA UDI	Class I	Active
UltraStim X	USX2020	EUDAMEDFDA UDI	Class I	Active
Pals	975250	EUDAMEDFDA UDI	Class I	Active
UltraStim Snap	SNC2040-D	EUDAMED	Class I	Active
ValuTrode	CFF125	EUDAMEDFDA UDI	Class I	Active
Pals X	PX2020	EUDAMEDFDA UDI	Class I	Active
actiTENS	Sublimed -SBM1AC006	EUDAMEDFDA UDI	Class I	Active
UltraStim Wire	UF2400	EUDAMEDFDA UDI	Class I	Active
UltraStim X Blue	USXB50100	EUDAMEDFDA UDI	Class I	Active
UltraStim X	USX2040	EUDAMEDFDA UDI	Class I	Active
PALS StimTrode	ST75D	EUDAMEDFDA UDI	Class I	Active
ValuTrode	CF5090	EUDAMEDFDA UDI	Class I	Active
PALS Clinical	210220	EUDAMEDFDA UDI	Class I	Active
Pals	896350	EUDAMEDFDA UDI	Class I	Active
ValuTrode	CT2750	EUDAMEDFDA UDI	Class I	Active
UltraStim Wire	UF1525	EUDAMEDFDA UDI	Class I	Active
UltraStim Wire	UF2020	EUDAMEDFDA UDI	Class I	Active
Pals	895402	EUDAMEDFDA UDI	Class I	Active
ValuTrode	CFF153	EUDAMEDFDA UDI	Class I	Active
ValuTrode	CFF275	EUDAMEDFDA UDI	Class I	Active
Pals	976230	EUDAMEDFDA UDI	Class I	Active
ValuTrode X	VTX5000	EUDAMEDFDA UDI	Class I	Active
ValuTrode X	VTX50100	EUDAMEDFDA UDI	Class I	Active
PALS StimTrode	ST510D	EUDAMEDFDA UDI	Class I	Active
ValuTrode	VTX2020	EUDAMEDFDA UDI	Class I	Active
ValuTrode	VTXT50100	EUDAMEDFDA UDI	Class I	Active
ValuTrode	CFF204	EUDAMEDFDA UDI	Class I	Active
ValuTrode	CF3200	EUDAMEDFDA UDI	Class I	Active
Pals	896240	EUDAMEDFDA UDI	Class I	Active
UltraStim Snap Derma	SND2020	EUDAMEDFDA UDI	Class I	Active
Little PALS	SEN 5001	EUDAMEDFDA UDI	Class I	Active

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