Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3031238386

FEI Number

3031238386

Entity Name

JIALE HEALTH TECHNOLOGY SHENZHEN CO., LTD.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

201, Builing A, No, 17, Guangjin Road, Shapu Community, Songgang Street, Bao 'an District, Shenzhen, China, Shenzhen Guangdong 518000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Jiale Health Technology Shenzhen Co., Ltd. (Owner Number: 10090635)

Owner / Operator Contact Address

201, Builing A, No, 17, Guangjin Road, Shapu Community, Songgang Street, Bao 'an District, Shenzhen, China, Shenzhen, CN-GD 518000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IRP	Massager, Powered Inflatable Tube	Physical Medicine	Class 2	890.5650	2025-03-24
IRO	Vibrator, Therapeutic	Physical Medicine	Class 1	890.5975	2025-03-24
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2024-04-22

Official Correspondent

Lijun Ling

US Agent Details

Mike Ryan Business: Simply Shipped, LLC Email: simplyshipped.agent@gmail.com Phone: (414) 3264114

Related Public Records

Same Entity

Jiale Health Technology Shenzhen 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
K242140	Jiale Health Technology Shenzhen Co., Ltd.	Air Compression Leg Massager (K-705)	2025-03-17
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 3031238386. Last updated year: 2026. Please use registration number 3031238386 when referencing this establishment in official correspondence.