Data / Medical devices / China / Shanghai Foreign Trade Enterprises Pudong Co., Ltd.
Shanghai Foreign Trade Enterprises Pudong Co., Ltd.: FDA-registered device maker in Shanghai, China, 2 510(k) clearances
Shanghai Foreign Trade Enterprises Pudong Co., Ltd. is registered with the FDA (registration 3004264602) in Shanghai, China. It lists 12 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 25, 2024. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3004264602
- Address
- 10-14 FL, No Zhao Jia Bang Road, Shanghai, China, 200031
- Owner or operator
- Shanghai Foreign Trade Enterprises Pudong Co., Ltd. (10081755)
- Roles
- Exporter to the US
- First device listed
- May 12, 2021
- Registered through
- 2026
- Brand names listed
- Eye Massager, FITRX RECOVERY HEAT PAD HP100/200, Foot Massager, Foot Spa Massager, Hand Massager, Hand Therapy ball, Head Massager, Knee Massager and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Pressure Applying | KNM | 1 | Exporter to the US | accessdata.fda.gov |
| Humidifier, Non-Direct Patient Interface (Home-Use) | KFZ | 1 | Exporter to the US | accessdata.fda.gov |
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Exporter to the US | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Exporter to the US | accessdata.fda.gov |
| Massager, Therapeutic, Manual | LYG | 1 | Exporter to the US | accessdata.fda.gov |
| Motor, Surgical Instrument, Pneumatic Powered | GET | 1 | Exporter to the US | accessdata.fda.gov |
| Orthosis, Thoracic | IPT | 1 | Exporter to the US | accessdata.fda.gov |
| Pack, Hot Or Cold, Reusable | IME | 1 | Exporter to the US | accessdata.fda.gov |
| Pad, Heating, Powered | IRT | 2 | Exporter to the US | accessdata.fda.gov |
| Stimulator, Muscle, Powered | IPF | 2 | Exporter to the US | accessdata.fda.gov |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | 2 | Exporter to the US | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | 2 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 25, 2024 | K240292 | Transcutaneous Electrical Nerve Stimulator (9029SCM) | NUH | Substantially Equivalent | Hong Kong Etech Groups Limited | accessdata.fda.gov |
| May 6, 2022 | K213788 | TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080) | NUH | Substantially Equivalent | Dongguan Bohuikang Technology Co.,Ltd | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Muscle, Powered
- All makers of Stimulator, Nerve, Transcutaneous, Over-The-Counter
- All makers of Stimulator, Muscle, Powered, For Muscle Conditioning
- All makers of Device, Pressure Applying
- All makers of Lamp, Infrared, Therapeutic Heating
- All makers of Humidifier, Non-Direct Patient Interface (Home-Use)
Updated March 25, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.