Question 1

What types of medical devices does Guangzhou Pinzhi Medical Technology Co., LTD manufacture?

Accepted Answer

Guangzhou Pinzhi Medical Technology Co., LTD specializes in devices for rehabilitation and circulation support. Their product line includes intermittent and sequential venous compression systems, pneumatic orthopaedic extracorporeal shock wave therapy systems, and bicycle exercisers. Examples of their devices are radial pressure pulse therapy systems, air wave pressure circulation massagers (for muscle stimulation and lymphatic drainage), and active-passive trainers for upper and lower limb mobility.

Question 2

Where is Guangzhou Pinzhi Medical Technology Co., LTD based?

Accepted Answer

The company is based in the United States, as indicated in their regulatory filings.

Question 3

Which regulatory registries list devices manufactured by Guangzhou Pinzhi Medical Technology Co., LTD?

Accepted Answer

Their devices appear in the FDA’s 510(k) registry for premarket notifications and the Ultralow Risk Device (UDI) registry, as some of their products fall under ULD exemptions. These registries track devices requiring clearance or those classified as low-risk.

Question 4

How are devices from Guangzhou Pinzhi Medical Technology Co., LTD classified under FDA regulations?

Accepted Answer

The company’s devices are classified as either Class I or Class II under FDA regulations. Class I devices generally pose minimal risk and may qualify for exemptions, while Class II devices require special controls to ensure safety and effectiveness. The classification determines whether a 510(k) clearance or other regulatory pathways apply.

Device	Model / Reference	Registries	Class	Status
Radial Pressure Pulse Therapy Device	PZ-3212	FDA UDI	Class I	Active
Air wave pressure circulation massager	PZ-3104F	FDA UDI	Class I	Active
Air wave pressure circulation massager	PZ-3105S	FDA UDI	Class I	Active
Air wave pressure circulation massager	PZ-3108L	FDA UDI	Class I	Active
Air wave pressure circulation massager	PZ-3122	FDA UDI	Class I	Active
Active Passive Trainer For Upper And Lower Limbs	PZ-5203	FDA UDI	Class I	Active
Radial Pressure Pulse Therapy Device	PZ-3201C	FDA UDI	Class I	Active
Radial Pressure Pulse Therapy Device	PZ-3201	FDA UDI	Class I	Active
Radial Pressure Pulse Therapy Device	PZ-3214M	FDA UDI	Class I	Active
Radial Pressure Pulse Therapy Device	PZ-3211	FDA UDI	Class I	Active
Radial Pressure Pulse Therapy Device	PZ-3212M	FDA UDI	Class I	Active
Radial Pressure Pulse Therapy Device	PZ-3202M	FDA UDI	Class I	Active
Air wave pressure circulation massager	PZ-3103D	FDA UDI	Class I	Active
Active Passive Trainer For Upper And Lower Limbs	PZ-5202	FDA UDI	Class I	Active
Air wave pressure circulation massager	PZ-3108	FDA UDI	Class I	Active
Radial Pressure Pulse Therapy Device	PZ-3202	FDA UDI	Class I	Active
Air wave pressure circulation massager	PZ-3104L	FDA UDI	Class I	Active
Active Passive Trainer For Upper And Lower Limbs	PZ-5201	FDA UDI	Class I	Active
Air wave pressure circulation massager	PZ-3106F	FDA UDI	Class I	Active
Air wave pressure circulation massager	PZ-3106	FDA UDI	Class I	Active
Air wave pressure circulation massager	PZ-3104	FDA UDI	Class I	Active
Active Passive Trainer For Upper And Lower Limbs	PZ-5204	FDA UDI	Class I	Active
Radial Pressure Pulse Therapy Device	PZ-3201P	FDA UDI	Class I	Active
Air wave pressure circulation massager	PZ-3106L	FDA UDI	Class I	Active
Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E)	K250033	FDA 510(k)	Class II	Active

Guangzhou Pinzhi Medical Technology Co., LTD

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