Foshan Hongfeng Co., Ltd.
Manufacturer and brand owner in Foshan, Guangdong, China. 24 device types, 2 products catalogued, 2 clearances.
Foshan Hongfeng Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Gag, Mouth, Mask, Oxygen and 22 other device types. 2 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2016.
24device types registered with the FDA
2products catalogued under its own name
2510(k) clearances
Registration
| Registered name | FOSHAN HONGFENG CO.,LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3013440654 |
| FEI number | 3013440654 |
| DUNS | 554404898 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 佛山鸿沣医疗科技有限公司 |
|---|---|
| Unified social credit code | 91440607MA4UT4WUXF |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Foshan |
|---|---|
| Province | Guangdong |
| Address | NO.4-2 LEQIANG ROAD ,LEPING SANSHUI |
| Postal code | 528100 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | Disposable face mask, Colour: white, blue, green, pink, Disposable medical face mask, Colour: white, blue, green, pink, Disposable surgical face mask, Colour: white, blue, green, pink | 2020 | 439 |
| Adaptor, Holder, Syringe | Class 1 | Decompression Belt | 2020 | 15 |
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | Class 2 | suction machine FO9001-A, suction machine FO9001-B | 2021 | 30 |
| Bag, Urine Collection, Leg, For External Use, Non-Sterile | Class 1 | Urine bag | 2020 | 47 |
| Bedding, Disposable, Medical | Class 1 | Body bag | 2020 | 308 |
| Cap, Surgical | Class 1 | Water bed | 2026 | 178 |
| Catheter, Nasal, Oxygen | Class 1 | Oxygen tube (Model: KT001) | 2021 | 14 |
| Device, Prosthesis Alignment | Class 1 | Cooling pad, Hand Rehabilitation System, Air cuffs for compression device | 2026 | 6 |
| Device, Rebreathing | Class 1 | oxygen concentrator | 2019 | 13 |
| Exerciser, Finger, Powered | Class 1 | Hand Rehabilitation system FO3002G, Hand Rehabilitation system FO3002H | 2025 | 9 |
| Gag, Mouth | Class 1 | Mouth Piece (Model: KM-003) | 2021 | 12 |
| Gown, Examination | Class 1 | Medical Disposible protective coverall | 2020 | 109 |
| Hand, External Limb Component, Powered | Class 1 | Cryo therapy | 2026 | 6 |
| Helmet, Surgical | Class 1 | Medical Goggles | 2020 | 7 |
| Mask, Oxygen | Class 1 | Oxygen Mask (Model: KM-001), Oxygen Mask (Model: KM-002) | 2021 | 126 |
| Mask, Scavenging | Class 1 | Face shield | 2020 | 158 |
| Massager, Powered Inflatable Tube | Class 2 | Air compression therapy systemFO3006, Smart-DVT Air Compression Therapy System FO-3002mini, Air compression therapy systemFO3002, Air compression therapy systemFO3009, Air compression therapy systemFO3007, Air compression therapy systemFO3005 and 9 more | 2021 | 37 |
| Massager, Therapeutic, Electric | Class 1 | Massage Machine, Beauty Machine, DVT Air Compression Therapy System FO-3002mini, Smart-DVT, Air compression therapy system FO3002 | 2016 | 437 |
| Mattress, Air Flotation, Alternating Pressure | Class 2 | Cushion, Alternating pressure mattress, medical air mattress | 2016 | 52 |
| Nebulizer (Direct Patient Interface) | Class 2 | BESMED Jet Nebulizer Bottle Set, Hsiner Jet Nebulizer | 2019 | 42 |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | Class 1 | disposable nebulizers, Nebulizer, Compressor Nebulizer (Model: BC68001, BC68002, BC6403, BC68005, BC68006) | 2021 | 57 |
| Pack, Hot Or Cold, Water Circulating | Class 2 | Cold therapy system | 2026 | 45 |
| Pump, Nebulizer, Electrically Powered | Class 1 | Nebulizer, Cool Mist Compressor | 2018 | 15 |
| Support, Arm | Class 1 | PL-22 Shoulder Sling | 2019 | 72 |
Own-Brand Listings
Clearances
2 clearances name Foshan Hongfeng 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 |
|---|---|---|---|---|
| K212169 | 2021-11-23 | IRP | Traditional | This company |
| K201982 | 2021-03-25 | IRP | Traditional | This company |
| 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 | 2016 |
|---|---|
| Main products | oscillating anti-decubitus mattress, air compression therapy systems, nebulizers, suction machines |
| Certifications | ISO 13485, ISO 9001, EU CE, FDA |
| Export markets | Western Europe, North America, South Asia |
| 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.