Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010605307

FEI Number

3010605307

Entity Name

IREST HEALTH SCIENCE AND TECHNOLOGY CO., LTD

City/State/Country

JIAXING CITY Zhejiang, CN

Establishment Address

No.1118 Shibali East Road, Daqiao Town, Nanhu District, Jiaxing, Zhejiang, China, NANHU DISTRICT, JIAXING CITY Zhejiang 314006, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

IREST HEALTH SCIENCE AND TECHNOLOGY CO., LTD (Owner Number: 10045441)

Owner / Operator Contact Address

No.1118 Shibali East Road, Daqiao Town, Nanhu District, Jiaxing, Zhejiang, China, NANHU DISTRICT, JIAXING CITY, CN-ZJ 314006, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

TAP MASSAGER Body Show Shaping Machine, SL-Y12 Handheld MASSAGER Body Show Shaping Machine MiNI MASSAGER MASSAGE BED MASSAGE CHAIR,BM-A228,BM-A229 Eye Massager Kneading Massage Cushion Tapping Massage Cushion Foot Massager, FMS-502HJ, SL-C807 SPA Massage Chair,BM-A228,BM-A229 Neck Massager Head Massager Knee Massager LEGS BEAUTICIAN

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IRO	Vibrator, Therapeutic	Physical Medicine	Class 1	890.5975	2013-11-18
KMN	Chair And Table, Medical	General Hospital	Class 1	880.6140	2013-11-18
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2013-11-18
ION	Exerciser, Non-Measuring	Physical Medicine	Class 1	890.5370	2013-11-18

Official Correspondent

Zhou Xianling

US Agent Details

Yueting Zhu Business: South Bay Innovation LLC Email: Huanwei001@outlook.com Phone: (424) 3769142

Related Public Records

Same Entity

IREST HEALTH SCIENCE AND 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
K821133	Durham Electric Co.	ELECTRICAL VIBRATING DEVICE	1982-07-09

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010605307. Last updated year: 2026. Please use registration number 3010605307 when referencing this establishment in official correspondence.