Hebei Newangie Technology Co., Ltd.
Registered establishment in Shijiazhuang, Hebei, China. 2 device types, 2 clearances.
Hebei Newangie Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Massager, Therapeutic, Electric, Powered Laser Surgical Instrument. Its earliest product listing with the FDA dates from 2024.
2device types registered with the FDA
2510(k) clearances
Registration
| Registered name | HEBEI NEWANGIE TECHNOLOGY CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3030543531 |
| FEI number | 3030543531 |
| Establishment type | Manufacturer |
Location
| City | Shijiazhuang |
|---|---|
| Province | Hebei |
| Address | Room 402, Building A-5, Guoxietang Industrial Park, No. 509 TaihangSouth Street, Hi-Tech Zone |
| Postal code | 050035 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Massager, Therapeutic, Electric | Class 1 | Roller massage lymphatic drainage device-M9+11S, Roller massage lymphatic drainage device-M9+10S, Roller massage lymphatic drainage device-RL10, Roller massage lymphatic drainage device-RL6, Roller massage lymphatic drainage device-M9+9S, Roller massage lymphatic drainage device-RL5 and 40 more | 2024 | 437 |
| Powered Laser Surgical Instrument | Class 2 | Diode laser device (BM091), Picosecond laser device (BMPS4) | 2025 | 92 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K252447 | 2025-10-01 | GEX | Traditional | This company |
| K251801 | 2025-08-08 | GEX | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2008 |
|---|---|
| Employees | 180+ |
| Factory area | 4000 square meters |
| Main products | Cosmetic Lasers, HIFU Devices, Cryolipolysis Machines, HIEMT EMS Sculpting, Shockwave Therapy Systems |
| Certifications | CE, FDA, ISO, CE-MDR, IEC, ICR MDR |
| Export markets | 110+ countries |
| OEM and ODM | Offered |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.