Shenzhen Fitconn Technology Co., Ltd.
Registered establishment in Shenzhen, Guangdong, China. 4 device types.
Shenzhen Fitconn Technology Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Compressor, Air, Portable, Nebulizer (Direct Patient Interface) and 2 other device types. Its earliest product listing with the FDA dates from 2019.
Registration
| Registered name | SHENZHEN FITCONN TECHNOLOGY CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3015219192 |
| FEI number | 3015219192 |
| Establishment type | Contract manufacturer, Complaint-file establishment, Manufacturer |
Chinese Registration
| Chinese legal name | 深圳市富迪康科技有限公司 |
|---|---|
| Unified social credit code | 91440300590702589T |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | 7th, Floor No.116 xiangshan road, luotian community, songgang street, Baoan |
| Postal code | 518105 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Compressor, Air, Portable | Class 2 | CNB69012, CNB69015, CNB69016, CNB69017, CNB69018, CNB69020, CNB69021, CNB69022, CNB69025, CNB69021S, CNB69025S, CNB69026, CDC100,CDC100B,CDC200,CDC200S,CDC300S,CDC500,CDC500S, CDC500B, COMPRESSOR NEBULIZER, Models: CNB69006,CNB69007,CNB69008,CNB69009,CNB69010, CNB69011, CNB69028, CNB69029, CNB69029S, CNB69031, CNB69031S | 2019 | 23 |
| Mattress, Air Flotation, Alternating Pressure | Class 2 | FU-AM006B, FU-AM006S, FU-AM006L, FU-AM006BL, FU-AM006SL, Anti Decubitus Mattress models FU-AM001,FU-AM001L,FU-AM002,FU-AM003,FU-AM004,FU-AM005,FU-AM006 | 2019 | 52 |
| Nebulizer (Direct Patient Interface) | Class 2 | CNB69018, CNB69020, CNB69021, CNB69022, CNB69025, CNB69021S, CNB69025S, CNB69026, CNB69028, CNB69029, CDC100,CDC100B,CDC200,CDC200S,CDC300S,CDC500,CDC500S, CDC500B, CNB69012, CNB69015, CNB69016, CNB69017, CNB69029S, CNB69031, CNB69031S,CNB69006,CNB69007,CNB69008,CNB69009,CNB69010, CNB69011, MY-123B, MY-125, MY-126, MY-130, MY-130B, MY-131, MY-138, MY-138B, MY-139, MY-139B, MY-151, MY-151B, MY-153, MY-153B,MY-123, MY-132, MY-132B, MY-133, MY-133B, MY-135, MY- 135B, MY-136, MY-136B | 2024 | 42 |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | Class 1 | MY-132, MY-132B, MY-133, MY-133B, MY-135, MY- 135B, MY-136, MY-136B, Nebulizer (Direct Patient Interface)-Mesh Nebulizer,Model MY-123, MY-123B, MY-125, MY-126, MY-130, MY-130B, MY-131, MY-138, MY-138B, MY-139, MY-139B, MY-151, MY-151B, MY-153, MY-153B | 2022 | 57 |
Clearances
No clearance names Shenzhen Fitconn Technology Co., Ltd. as applicant. 2 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 |
|---|---|---|---|---|
| K201397 | 2021-06-14 | CAF | Traditional | Shenzhen Ivankaca Technology Co., Ltd. |
| K091272 | 2009-11-10 | CAF | Traditional | Besmed Health Business Corporation |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2012 |
|---|---|
| Main products | Compressor nebulizer, Mesh nebulizer, Anti-decubitus air mattress, Blood pressure monitor, Pulse oximeter |
| Export markets | 150+ 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.