Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030220267

FEI Number

3030220267

Entity Name

GUANGZHOU PINZHI MEDICAL TECHNOLOGY CO., LTD

City/State/Country

Guangzhou Guangdong, CN

Establishment Address

44-2, Xiangshan Avenue, Ningxi Street,Zengcheng District, Guangzhou Guangdong 510000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Guangzhou Pinzhi Medical Technology Co., LTD (Owner Number: 10089203)

Owner / Operator Contact Address

44-2, Xiangshan Avenue, Ningxi Street,Zengcheng District, Guangzhou, CN-GD 510000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K250033

PMA Number

N/A

All Registered Proprietary Names

Focused Extracorporeal ShockWave Therapy Machine Radial Extracorporeal ShockWave Therapy Machine Active Passive Trainer For Upper And Lower Limbs Focused Extracorporeal ShockWave Therapy Machine Radial Extracorporeal ShockWave Therapy Machine Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2023-11-15
BXB	Exerciser, Powered	Physical Medicine	Class 1	890.5380	2023-11-15
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2023-11-15
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2026-05-13
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2026-05-13

Official Correspondent

Xianqing Huang

US Agent Details

Weian Huang Business: JOYSUN USA LLC Email: weian@isosh.com Phone: (949) 4624543

Related Public Records

Same Entity

Guangzhou Pinzhi Medical Technology Co., LTD

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K221200	Xbody Hungary Kft.	XBody Go USA, XBody Pro USA	2023-01-31

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030220267. Last updated year: 2026. Please use registration number 3030220267 when referencing this establishment in official correspondence.