Question 1

What types of medical devices does Smart Home Branch of Zhangzhou Easepal Industrial Corporation manufacture?

Accepted Answer

The company produces battery-powered devices primarily for home use, including handheld electric massagers, foot baths with massage jets, and electric massagers designed for beds and chairs. These devices are intended to relieve muscle tension and improve circulation through techniques like vibration, percussion, or rolling massage.

Question 2

Where is Smart Home Branch of Zhangzhou Easepal Industrial Corporation based?

Accepted Answer

The company operates from the United States, as indicated in its regulatory documentation. This location is relevant for understanding the jurisdiction under which its devices are authorised.

Question 3

Which regulatory registries list the devices manufactured by Smart Home Branch of Zhangzhou Easepal Industrial Corporation?

Accepted Answer

The company’s devices are registered in the FDA’s UDI (Unique Device Identification) database. This system is used to track and identify medical devices authorised in the U.S., ensuring traceability and compliance.

Question 4

How are the devices manufactured by Smart Home Branch of Zhangzhou Easepal Industrial Corporation classified under U.S. regulations?

Accepted Answer

All listed devices fall under Class I regulatory classification in the U.S. This classification applies to low-risk devices that pose minimal potential harm to users, such as many home-use massagers and foot baths. Class I devices typically require general controls to ensure safety and effectiveness.

Device	Model / Reference	Registries	Class	Status
Homedics	HHP-285HJB-2	FDA UDI	Class I	Active
Medisana	EM 500	FDA UDI	Class I	Active
Homedics	FB-50J-BK-2	FDA UDI	Class I	Active
Homedics	HHP-285HJ-2	FDA UDI	Class I	Active
Homedics	FB-50J-2	FDA UDI	Class I	Active
Homedics	FMV-400HJ-BK-2	FDA UDI	Class I	Active
Homedics	FB-52JA-PK-2	FDA UDI	Class I	Active
Homedics	FMV-400HJA-BK-2	FDA UDI	Class I	Active
Homedics	HHP-285HJA-2	FDA UDI	Class I	Active
Medisana	HM 305B	FDA UDI	Class I	Active
Homedics	FB-52J-2	FDA UDI	Class I	Active
Homedics	MCS-116HJA-2	FDA UDI	Class I	Active
Homedics	MCS-116HJ-2	FDA UDI	Class I	Active
Homedics	FB-50JB-BL-2	FDA UDI	Class I	Active
Homedics	FMV-400HJ-GY-2	FDA UDI	Class I	Active
Homedics	HHP-285HJC-2	FDA UDI	Class I	Active
Homedics	SP-6HJ-GY-2	FDA UDI	Class I	Active
Homedics	FB-50JA-BL-2	FDA UDI	Class I	Active
Homedics	B-FMS-110HJ-2	FDA UDI	Class I	Active
Homedics	FMV-400HJB-BK-2	FDA UDI	Class I	Active
Homedics	FB-50J-BL-2	FDA UDI	Class I	Active
Homedics	FB-52JA-FD	FDA UDI	Class I	Active
Homedics	FB-52J	FDA UDI	Class I	Active
Homedics	HHP-231J-2	FDA UDI	Class I	Active
Homedics	FB-52JB-PK-2	FDA UDI	Class I	Active
Brookstone	B-SP-8J-2	FDA UDI	Class I	Active
Homedics	SP-6HJ-2	FDA UDI	Class I	Active
Homedics	HHP-231JA-2	FDA UDI	Class I	Active
Homedics	SP-6HJA-2	FDA UDI	Class I	Active
Homedics	FB-52J-PK-2	FDA UDI	Class I	Active
Medisana	HM 305	FDA UDI	Class I	Active
Homedics	SP-6HJA-GY-2	FDA UDI	Class I	Active

Smart Home Branch of Zhangzhou Easepal Industrial Corporation

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