Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3024379416

FEI Number

3024379416

Entity Name

EHEALTH SCIENCE AND TECHNOLOGY(HONG KONG) CO., LTD

City/State/Country

Hongkong, HK

Establishment Address

FLAT/RM 04-05 16/F THE BROADWAY NO 54-62 LOCKHART ROAD WANCHAI, Hongkong 000000, HK

Establishment Type(s)

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

Owner / Operator

EHEALTH SCIENCE AND TECHNOLOGY(HONG KONG) CO., LTD (Owner Number: 10086256)

Owner / Operator Contact Address

FLAT/RM 04-05 16/F THE BROADWAY NO 54-62 LOCKHART ROAD WANCHAI, Hongkong, HK-NOTA 000000, HK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K161938

PMA Number

N/A

All Registered Proprietary Names

EYE MASSAGER DX-206,DX-207,DX-208,DX-300.DX-301,DX-302 ,MC1 Fingertip Pulse Oximeter, YK-83C MB1

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	2024-07-03
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2022-10-25

Official Correspondent

No official correspondent registered.

US Agent Details

Charles Mack Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

EHEALTH SCIENCE AND TECHNOLOGY(HONG KONG) 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
K903523	Hewlett-Packard Co.	HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE	1990-10-23
K973147	Nellcor Puritan Bennett, Inc.	NPB-295 PULSE OXIMETER	1997-11-14
K231243	Guangdong Genial Technology Co., Ltd.	Finger Clip Pulse Oximeter	2023-10-31
K971628	Somanetics Corp.	SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS)	1997-10-10
K153184	Shenzhen Caremed Medical Technology Co., Ltd.	Caremed Reusable & Disposable SPO2 Sensors	2017-01-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
Z-0028-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M, Part Number CS08653
Z-0029-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M W/PRINTER, Part Number CS08659

Similar Registrations

Registration Number	Establishment Name	Location
3016460723	ZHEJIANG AOLIN INDUSTRY & TRADE CO., LTD.	Lishui Zhejiang, CN
3032903908	TECHDERM LLC	Palm Beach Gardens, FL, US
3030407739	CL MEDIX INC	Chantilly, VA, US
3009079475	Aerotel Ltd.	Holon Central, IL
3025350087	LENYO WORLD LTD	Budapest, HU

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3024379416. Last updated year: 2026. Please use registration number 3024379416 when referencing this establishment in official correspondence.