Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004264602

FEI Number

3004264602

Entity Name

SHANGHAI FOREIGN TRADE ENTERPRISES PUDONG CO., LTD.

City/State/Country

Shanghai, CN

Establishment Address

10-14 FL, No 258-268 Zhao Jia Bang Road,, Shanghai 200031, CN

Establishment Type(s)

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

Owner / Operator

Shanghai Foreign Trade Enterprises Pudong Co., Ltd. (Owner Number: 10081755)

Owner / Operator Contact Address

10-14 FL, No 258-268 Zhao Jia Bang Road,, Shanghai, CN-SH 200031, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MINI NANO FACIAL MIST SPRAYER SLF NANO MIST FACIAL STEAMER N/A FITRX RECOVERY HEAT PAD HP100/200 Transcutaneous Electrical Nerve Stimulator (9029SCM) SLF CRYOSLEEVE LG SLF CRYOSLEEVE MEDIUM SLF HOT/COLD NECK PILLOW LED LIGHT THERAPY DEVICE Tzumi FitRx Stimulator Smart Cupping 30357, 30590 Mountable massage ball Massage ball Hand Therapy ball

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KFZ	Humidifier, Non-Direct Patient Interface (Home-Use)	Anesthesiology	Class 1	868.5460	2022-06-24
GET	Motor, Surgical Instrument, Pneumatic Powered	General, Plastic Surgery	Class 1	878.4820	2024-09-30
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2024-06-26
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2024-10-15
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2024-10-15
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2022-06-24
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2024-10-15
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2023-06-20
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2023-06-20
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2023-06-20
KNM	Device, Pressure Applying	Physical Medicine	Class 1	890.5765	2025-08-16
LYG	Massager, Therapeutic, Manual	Physical Medicine	Class 1	890.5660	2021-07-21

Official Correspondent

Charles Shen

US Agent Details

Charles Shen Business: Manton Business and Technology Services Email: cyshen@aol.com Phone: (608) 2179358

Related Public Records

Same Entity

Shanghai Foreign Trade Enterprises Pudong 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
K953432	Midas Rex Pneumatic Tools, Inc.	ROTATING, FIXED FOOTED, FIXED SHIELD ATTACHMENTS, DISSECTING TOOLS	1995-09-14
K881862	Thermo Body Wrap Systems, Inc.	THERMO-BODY-WRAP SYSTEM	1988-10-13
K221200	Xbody Hungary Kft.	XBody Go USA, XBody Pro USA	2023-01-31
K030403	Cefar Medical AB	CEFAR REHAB 2 AND REHAB 2 PRO	2003-07-17
K231440	Shenzhen Roundwhale Technology Co. , Ltd.	Combo Electrotherapy Device	2023-11-03

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3022528821	J SUMMIT CO., LTD.	Chomthong Krung Thep Maha Nakhon, TH
3011919098	NINGBO JUST SOON INDUSTRIAL LIMITED	Ningbo Zhejiang, CN
1419185	Ohio Medical LLC	Gurnee, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004264602. Last updated year: 2026. Please use registration number 3004264602 when referencing this establishment in official correspondence.