Shenzhen Sany Pioneer Technology Co., Ltd.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 9 device types, 4 products catalogued.
Shenzhen Sany Pioneer Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Mask, Oxygen, Dilator, Nasal and 7 other device types. 4 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2022.
Registration
| Registered name | SHENZHEN SANY PIONEER TECHNOLOGY CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3016674860 |
| FEI number | 3016674860 |
| DUNS | 415478661 |
| Establishment type | Manufacturer |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | 503A, 302, No.2 Factory Building, Fukang Road, |
| Postal code | 518000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Condenser, Heat And Moisture (Artificial Nose) | Class 1 | Cartridges Humi DX F20, Humidifiers Humidx F20 | 2026 | 29 |
| Device, Anti-Snoring | Class 2 | Joybloom Anti Snoring Mouthpiece L09, Innoflow Anti Snoring Mouthpiece L09, Willnice Anti Snoring Mouthpiece L09, Wedoheal Anti Snoring Mouthpiece L08, Innoflow Anti Snoring Mouthpiece L08, Willnice Anti Snoring Mouthpiece L08 and 6 more | 2025 | 8 |
| Device, Jaw Repositioning | Class 2 | Joybloom Anti Snoring Mouthpiece L09, Innoflow Anti Snoring Mouthpiece L09, Willnice Anti Snoring Mouthpiece L09, Willnice Anti Snoring Mouthpiece L07, Wedoheal Anti Snoring Mouthpiece L07, Everness Anti Snoring Mouthpiece L07 and 2 more | 2025 | 4 |
| Dilator, Nasal | Class 1 | Nasal Dilator (BK01, BK02, BK0), Nasal Strips for Snoring (BK01, BK02, B0) | 2026 | 55 |
| Humidifier, Non-Direct Patient Interface (Home-Use) | Class 1 | Upgraded Humidifiers Humidx F20, Cartridges Humi DX F20 for Airmini CPAP Machines, Humi DX Compatible with N20/P10 Connector for AirMini | 2026 | 55 |
| Mask, Oxygen | Class 1 | Mask Set | 2022 | 126 |
| Set, Tubing And Support, Ventilator (W Harness) | Class 1 | Replacement Short Tube Adapter for Airmini, CPAP Tubing Assembly, CPAP Tube | 2026 | 33 |
| Strap, Head, Gas Mask | Class 1 | Headgear, Headgear Strap, Headbands | 2022 | 29 |
| Ventilator, Non-Continuous (Respirator) | Class 2 | Cushion, CPAP Mask Set, Elbow | 2026 | 18 |
Own-Brand Listings
Clearances
No clearance names Shenzhen Sany Pioneer Technology Co., Ltd. as applicant. 4 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K262104 | 2026-08-27 | LRK | Special | Ram.Shaw Pte., Ltd. |
| K251920 | 2026-05-21 | BZD | Traditional | Dcstar, Inc. |
| K253845 | 2026-03-03 | LRK | Traditional | Ram.Shaw Pte., Ltd. |
| K251628 | 2025-10-22 | LRK | Traditional | Dcstar, Inc. |
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.