Question 1

What types of medical devices does Heartway Medical Products Co., Ltd primarily manufacture?

Accepted Answer

Heartway Medical Products Co., Ltd specializes in mobility aids, focusing on power-assisted and occupant-controlled wheelchairs, as well as electric-motor-driven assistive scooters. Their product line includes collapsible and non-collapsible designs, with rear-wheel operation for occupant-driven wheelchairs. These devices are designed to assist individuals with limited mobility.

Question 2

Where is Heartway Medical Products Co., Ltd based?

Accepted Answer

Heartway Medical Products Co., Ltd is headquartered in the United States. The company’s location is relevant for regulatory compliance, manufacturing oversight, and customer support related to its mobility devices.

Question 3

Which regulatory registries or databases list Heartway Medical Products Co., Ltd’s devices?

Accepted Answer

Heartway Medical Products Co., Ltd’s devices are listed in the FDA’s UDI (Unique Device Identification) system. This registry ensures traceability and transparency for healthcare providers, regulators, and patients by assigning a unique identifier to each device, facilitating tracking and compliance.

Question 4

How are Heartway Medical Products Co., Ltd’s devices classified under FDA regulations?

Accepted Answer

Heartway Medical Products Co., Ltd’s devices fall under FDA’s Class I and Class II classifications. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher risk and may require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway for authorization.

Device	Model / Reference	Registries	Class	Status
Heartway Medical Products Co., Ltd	HP4	FDA UDI	Class II	Active
Heartway Medical Products Co., Ltd	P27	FDA UDI	Class II	Active
Heartway Medical Products Co., Ltd	P15	FDA UDI	Class II	Active
Heartway Medical Products Co., Ltd	P19	FDA UDI	Class II	Active
Heartway Medical Products Co., Ltd	HP3HD	FDA UDI	Class II	Active
Heartway Medical Products Co., Ltd	S9	FDA UDI	Class II	Active
Heartway Medical Products Co., Ltd	P3D	FDA UDI	Class II	Active
Heartway Medical Products Co., Ltd	MANUAL WHEELCHAIR	FDA UDI	Class I	Active
Heartway Medical Products Co., Ltd	S11	FDA UDI	Class II	Active
Heartway Medical Products Co., Ltd	S12	FDA UDI	Class II	Active
Heartway Medical Products Co., Ltd	P4R	FDA UDI	Class II	Active
Heartway Medical Products Co., Ltd	TC1	FDA UDI	Class II	Active
Heartway Medical Products Co., Ltd	S33	FDA UDI	Class II	Active
Heartway Medical Products Co., Ltd	P23	FDA UDI	Class II	Active
Heartway Medical Products Co., Ltd	P13	FDA UDI	Class II	Active
Heartway Medical Products Co., Ltd	S15	FDA UDI	Class II	Active
Heartway Medical Products Co., Ltd	P33	FDA UDI	Class II	Active
Heartway Medical Products Co., Ltd	HP7	FDA UDI	Class II	Active
Heartway Medical Products Co., Ltd	P16RT	FDA UDI	Class II	Active
Heartway Medical Products Co., Ltd	P4AS	FDA UDI	Class II	Active
Heartway Medical Products Co., Ltd	S34	FDA UDI	Class II	Active
Heartway Medical Products Co., Ltd	P14	FDA UDI	Class II	Active
Heartway Medical Products Co., Ltd	HPS	FDA UDI	Class II	Active
Heartway Medical Products Co., Ltd	P17RT	FDA UDI	Class II	Active
Heartway Medical Products Co., Ltd	PF3	FDA UDI	Class II	Active

HEARTWAY MEDICAL PRODUCTS CO., LTD.

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