Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013431847

FEI Number

3013431847

Entity Name

SHENZHEN OCEANUS MEDICAL DEVICE CO., LTD.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

No 2 East Side, F2, Yinjin Building, 3 Liuxian Road, 71 Xin An Zone, Xin An Subdistrict, Bao An District, Shenzhen Guangdong 518101, CN

Establishment Type(s)

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

Owner / Operator

Shenzhen Oceanus Medical Device Co., Ltd. (Owner Number: 10053056)

Owner / Operator Contact Address

No 2 East Side, F2, Yinjin Building, 3 Liuxian Road, 71 Xin An Zone, Xin An Subdistrict, Bao An District, Shenzhen, CN-GD 518101, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Oceanus Therapy Device, Model OCE-ESWT-003 Oceanus Therapy Device, Model OCE-DMST-001, Oceanus Therapy Device, Model OCE-DMST-002 Oceanus Therapy Device, Model OCE-ETUS-001 Oceanus Therapy Device, Model OCE-ETUS-003 Oceanus Therapy Device, Model OCE-WLTS-001 Oceanus Therapy Device, Model OCE-REFS-002 Oceanus Therapy Device, Model OCE-ETUS-004 Oceanus Therapy Device, Model OCE-ETUS-005 Oceanus Therapy Device, Model OCE-EMST-001, Oceanus Therapy Device, Model OCE-EMST-002 Oceanus Therapy Device, Model OCE-MSLS-001, Oceanus Therapy Device, Model OCE-MSLS-002 Oceanus Therapy Device, Model OCE-ESWT-002 Oceanus Therapy Device, Model OCE-WLTS-002 Oceanus Therapy Device, Model OCE-ESWT-003 (Type II) Oceanus Therapy Device, Model OCE-ESWT-001 Oceanus Therapy Device, Model OCE-ESWT-004 Oceanus Therapy Device, Model OCE-ETUS-002 Oceanus Therapy Device, Model OCE-ETUS-002 (Type II) Oceanus Therapy Device, Model OCE-REFS-001

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	2016-10-26

Official Correspondent

James Feng

US Agent Details

Suleyman Bilgutay Business: Infinium Medical., Inc. Email: cyshen@aol.com Phone: (727) 4558160

Related Public Records

Same Entity

Shenzhen Oceanus Medical Device Co., Ltd.

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013431847. Last updated year: 2026. Please use registration number 3013431847 when referencing this establishment in official correspondence.