Fofo Medical Co., Ltd.
Registered establishment in Xiamen, Fujian, China. 18 device types.
Fofo Medical Co., Ltd. is an exporter holding a current FDA establishment registration. The registration covers Support, Arm, Helmet, Surgical and 16 other device types. Its earliest product listing with the FDA dates from 2026.
Registration
| Registered name | FOFO MEDICAL CO.,LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3045077467 |
| FEI number | 3045077467 |
| Establishment type | Exporter |
Chinese Registration
| Chinese legal name | 福浩醫療有限公司 |
|---|---|
| Source | Hong Kong company register lookup |
Location
| City | Xiamen |
|---|---|
| Province | Fujian |
| Address | Room 1212A, No. 108 Hexiang East Road, Siming District, |
| Postal code | 361001 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | Disposable surgical face mask, Colour: white, blue, green, pink, Disposable medical face mask, Colour: white, blue, green, pink, Disposable face mask, Colour: white, blue, green, pink | 2026 | 439 |
| Adaptor, Holder, Syringe | Class 1 | Decompression Belt | 2026 | 15 |
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | Class 2 | suction machine FO9001-B, suction machine FO9001-A | 2026 | 30 |
| Bag, Urine Collection, Leg, For External Use, Non-Sterile | Class 1 | Urine bag | 2026 | 47 |
| Bedding, Disposable, Medical | Class 1 | Body bag | 2026 | 308 |
| Catheter, Nasal, Oxygen | Class 1 | Oxygen tube (Model: KT001) | 2026 | 14 |
| Device, Rebreathing | Class 1 | oxygen concentrator | 2026 | 13 |
| Exerciser, Finger, Powered | Class 1 | Hand Rehabilitation system FO3002G, Hand Rehabilitation system FO3002H | 2026 | 9 |
| Gown, Examination | Class 1 | Medical Disposible protective coverall | 2026 | 109 |
| Helmet, Surgical | Class 1 | Medical Goggles | 2026 | 7 |
| Massager, Powered Inflatable Tube | Class 2 | Air compression therapy systemFO3004, Air compression therapy systemFO3002, Air compression therapy systemFO3007, Air compression therapy systemFO3003, Air compression therapy systemFO3009, Smart-DVT Air Compression Therapy System FO-3002mini and 9 more | 2026 | 37 |
| Massager, Therapeutic, Electric | Class 1 | Smart-DVT, Massage Machine, Beauty Machine, DVT Air Compression Therapy System FO-3002mini, Air compression therapy system FO3002 | 2026 | 437 |
| Mattress, Air Flotation, Alternating Pressure | Class 2 | Alternating pressure mattress, Cushion, medical air mattress | 2026 | 52 |
| Nebulizer (Direct Patient Interface) | Class 2 | Hsiner Jet Nebulizer, BESMED Jet Nebulizer Bottle Set | 2026 | 42 |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | Class 1 | Compressor Nebulizer (Model: BC68001, BC68002, BC6403, BC68005, BC68006), Nebulizer, disposable nebulizers | 2026 | 57 |
| Pack, Hot Or Cold, Water Circulating | Class 2 | Cold Therapy System | 2026 | 45 |
| Pump, Nebulizer, Electrically Powered | Class 1 | Nebulizer, Cool Mist Compressor | 2026 | 15 |
| Support, Arm | Class 1 | PL-22 Shoulder Sling | 2026 | 72 |
Clearances
No clearance names Fofo Medical 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 |
|---|---|---|---|---|
| K212169 | 2021-11-23 | IRP | Traditional | Foshan Hongfeng Co., Ltd. |
| K201982 | 2021-03-25 | IRP | Traditional | Foshan Hongfeng Co., Ltd. |
| K091272 | 2009-11-10 | CAF | Traditional | Besmed Health Business Corporation |
| K052811 | 2005-12-21 | CAF | Traditional | Hsiner Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2014 |
|---|---|
| Employees | 420+ |
| Factory area | 30,000 m² |
| Main products | Medical air mattresses, Nebulizers, Suction machines, Air compression therapy, Water mattresses |
| Certifications | ISO 13485, CE/MDR, FDA, CFDA, FSC, NRTL, MHRA, ANVISA |
| Export markets | 100+ 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.