Data / Medical devices / China / Shenzhen Sungpo Hi-Tech Electronic Co., Ltd
Shenzhen Sungpo Hi-Tech Electronic Co., Ltd: FDA-registered device maker in Shenzhen Guangdong, China, 1 510(k) clearance
Shenzhen Sungpo Hi-Tech Electronic Co., Ltd is registered with the FDA (registration 3016071154) in Shenzhen Guangdong, China. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 5, 2023. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3016071154
- Address
- Room 318, Chuangke Building, 72-6 Huanguan South Road Xintian Community, Guanhu Street, Longhua District, Shenzhen Guangdong, China, 518110
- Owner or operator
- Shenzhen SUNGPO Hi-Tech Electronic Co., Ltd (10062316)
- Roles
- Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer
- First device listed
- January 12, 2020
- Registered through
- 2026
- Brand names listed
- LED Facial Mask; model(s): MZ-01, NEWKEY-01, SP-FM-01, ZK-01, SP-BM-561, SP-BM-562, SP-BM-563, SP-BM-564, Light Therapy Ankle Sleeve; model(s): SP-AS-501, SP-AS-502, SP-AS-503, Light Therapy Belt; model(s): SP-RB-501, SP-RB-502, SP-RB-503, SP-RB-504, SP-RB-505, SP-RB-506, Light Therapy Devices; model(s): see lines [L11-L12], Light Therapy Glove; model(s): SP-LG-501, SP-LG-502, SP-LG-503, Light Therapy Knee Pad; model(s): SP-KP-501, SP-KP-502, SP-KP-503, Light Therapy Neck Pad; model(s): SP-NP-501,SP-NP-502,SP-NP-503, Light Therapy Shawl; model(s): SP-LS-501, SP-LS-502, SP-LS-503 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Exerciser, Finger, Powered | JFA | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Contract manufacturer, Foreign private label distributor, Manufacturer | accessdata.fda.gov |
| Light Based Over The Counter Wrinkle Reduction | OHS | 2 | Manufacturer | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Over-The-Counter Powered Light Based Laser For Acne | OLP | 2 | Manufacturer | accessdata.fda.gov |
| Vibrator, Therapeutic | IRO | 1 | Contract manufacturer, Exporter to the US, Manufacturer | 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 |
|---|---|---|---|---|---|---|
| May 5, 2023 | K230351 | LED Facial Mask | OHS | Substantially Equivalent | Shenzhen Sungpo Hi-Tech Electronic Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Exerciser, Finger, Powered
- All makers of Massager, Therapeutic, Electric
- All makers of Over-The-Counter Powered Light Based Laser For Acne
- All makers of Light Based Over The Counter Wrinkle Reduction
- All makers of Vibrator, Therapeutic
- All makers of Lamp, Infrared, Therapeutic Heating
Updated May 5, 2023. 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.