Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016425406

FEI Number

3016425406

Entity Name

WENZHOU ZHIRONG HEALTH & SCIENCE TECHNOLOGY CO., LTD

City/State/Country

Wenzhou Zhejiang, CN

Establishment Address

A12-3, Small and Micro Garden, West Kunyang, Pingyang Town, Wenzhou Zhejiang 325400, CN

Establishment Type(s)

Manufacture Medical Device,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Wenzhou Zhirong Health & Science Technology Co., Ltd (Owner Number: 10061866)

Owner / Operator Contact Address

No. 129, North Liandong Road, Clothing Garden, Wenzhou, CN-ZJ 325400, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CoreWave,PP6218 Infinity Aura Elite, Kyota M780 Yugana, Kyota M380 Genki Massage Chair Model Z100, Z200, Z300, FMP-11, HY-5085, HY-5082A

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	2019-11-26

Official Correspondent

Wan Zhong

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: Regrek.Cs@Hotmail.Com Phone: (302) 6089028

Related Public Records

Same Entity

Wenzhou Zhirong Health & Science Technology Co., Ltd

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016425406. Last updated year: 2026. Please use registration number 3016425406 when referencing this establishment in official correspondence.