Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014830562

FEI Number

3014830562

Entity Name

HANGZHOU ZHENGDA MEDICAL CO.,LTD

City/State/Country

Hangzhou Zhejiang, CN

Establishment Address

501, No.22, Xinyan Road, Yuhang Economic Development Zone, Linping District, Hangzhou Zhejiang 311100, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Hangzhou Zhengda Medical CO.,LTD (Owner Number: 10094712)

Owner / Operator Contact Address

501, No.22, Xinyan Road, Yuhang Economic Development Zone, Linping District, Hangzhou, CN-ZJ 311100, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Massage,therapeutic,electric(Massage System) Compression Therapy System 30"*4"; 30"*5.1"; 34"*4"; 34"*5.1"; 38"*4"; 38"*5.1"; 43"*5.1"; 44"*4" Reusable conical cuff: 25"*3.5"; 30"*3.5"; 35"*4.5"; 43"*5"; 24"*4"; 30"*4.1"; 34"*4.3"; 43"*5" Disposable Tourniquet Cuff: 10"*2"; 20"*6"; 26"*6"; 32"*6"; 8"*2"; 8"*2.5"; 12"*3"; 12"*3.5"; 15"*4"; 18"*4"; 24"*4"; Reusable Tourniquet Cuff: 8"*2"; 8"*2.5"; 12"*3"; 12"*3.5"; 15"*4"; 18"*4"; 24"*4"; 30"*4"; 30"*5.1"; 34"*4"; Disposable Conical Cuff:24" *4" ; 30" * 4.1" ; 34" *4.3" ; 43"*5"; Automatic Tourniquet System 34"*5.1"; 38"*4"; 38"*5.1"; 44"*4"; 43"*5.1"; 10"*2"; 14"*4"; 20"*6"; 26"*6"; 32"*6" EXERCISER, POWERED (Continuous Passive Motion Finger CPM-finger; CPM) INSTRUMENT, CAST REMOVAL, AC-POWERED (Medical Electric Plaster Saw) PAD,HEATING,POWERED (Hyperthermia System)

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	2025-12-17
KCY	Tourniquet, Pneumatic	General, Plastic Surgery	Class 1	878.5910	2025-12-17
BXB	Exerciser, Powered	Physical Medicine	Class 1	890.5380	2025-12-17
LGH	Instrument, Cast Removal, Ac-Powered	Orthopedic	Class 1	888.5960	2025-12-17
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2025-12-17

Official Correspondent

Shuhua Zhang

US Agent Details

Jimmy Chen Business: Hyun Turle E-Commerce Inc Email: Kin.grace@hotmail.com Phone: (626) 6273399

Related Public Records

Same Entity

Hangzhou Zhengda Medical 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
K881862	Thermo Body Wrap Systems, Inc.	THERMO-BODY-WRAP SYSTEM	1988-10-13

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014830562. Last updated year: 2026. Please use registration number 3014830562 when referencing this establishment in official correspondence.