Shenzhen Lifotronic Technology Co., Ltd.
Registered establishment in Shenzhen, Guangdong, China. 5 device types, 2 clearances.
Shenzhen Lifotronic Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Bottle, Collection, Vacuum, Massager, Therapeutic, Electric and 3 other device types. Its earliest product listing with the FDA dates from 2019.
5device types registered with the FDA
2510(k) clearances
Registration
| Registered name | Shenzhen Lifotronic Technology Co.,Ltd. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3012289707 |
| FEI number | 3012289707 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 广东普门生物医疗科技有限公司 |
|---|---|
| Unified social credit code | 91440300671851383C |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | Lifotronic Tower, No. 8, Qiuzhi East Road, Guancheng Community, Guanhu Street |
| Postal code | 518110 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Bottle, Collection, Vacuum | Class 2 | Canister(CL1000; CL500; CS300; CS500) | 2020 | 88 |
| Massager, Powered Inflatable Tube | Class 2 | Air Compression Therapy System | 2020 | 37 |
| Massager, Therapeutic, Electric | Class 1 | Shock Wave Therapy System(LC-310; LC-320; LC-560; LC-570; LC-580;UW210), Airway Clearance System | 2019 | 437 |
| Powered Laser Surgical Instrument | Class 2 | Diode Laser Hair Removal Machine(models:T60A, T60B, T60C, T60D, T60E) | 2025 | 92 |
| Reagent, Coronavirus Serological | Class N | SARS- CoV-2 lgM Assay Kits (Lateral Flow Immunoassay), SARS-CoV-2 IgG (Electrochemiluminescence Immunoassay), SARS- CoV-2 lgG Assay Kits (Lateral Flow Immunoassay), SARS-CoV-2 IgM (Electrochemiluminescence Immunoassay) | 2020 | 12 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K251076 | 2025-07-30 | GEX | Traditional | This company |
| K192466 | 2020-06-22 | IRP | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2008 |
|---|---|
| Employees | 1500+ |
| Factory area | 150000 m² |
| Main products | HPLC systems, ECLIA systems, Hematology analyzers, Medical lasers, Therapeutic products |
| Export markets | 120+ countries |
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.
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