Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016427447

FEI Number

3016427447

Entity Name

ISA MOULD ENGINEERING LIMTED

City/State/Country

Dongguan Guangdong, CN

Establishment Address

No. 7 Shuiku Rd Sha Tou, Changan Town, Dongguan Guangdong 523861, CN

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

ISA MOULD ENGINEERING LIMTED (Owner Number: 10084901)

Owner / Operator Contact Address

Shuiku Rd Sha Tou (Spb-A) Room 201, No. 7 Bldgno.7-1 No.7; Changan Town, Dongguan, CN-GD 523870, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Pacifier , soother

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2022-04-13
HCC	Device, Biofeedback	Neurology	Class 2	882.5050	2026-01-14

Official Correspondent

Jane Tsou

US Agent Details

Hardy He Business: ISA MOULD ENGINEERING LIMITED Email: info@isa-mould.com Phone: (805) 3463700

Related Public Records

Same Entity

ISA MOULD ENGINEERING LIMTED

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
K873418	Bodylog, Inc.	BODYLOG STRESS REDUCTION PACKAGE	1987-12-17
K792659	Bio-Feedback Systems, Inc.	FEEDBACK EDR SYSTEM MODEL ME-1	1980-01-09

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3029987245	FLAUS, INC.	New York, NY, US
3013257234	MINGZHEN (DONGGUAN) ELECTRONICS CO., LTD	Dongguan Guangdong, CN
3038200340	WEIFANG YANGXU LABOR PROTECTION PRODUCTS CO., LTD	Weifang Shandong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016427447. Last updated year: 2026. Please use registration number 3016427447 when referencing this establishment in official correspondence.