FDA Registration
Active
🇨🇳 China
FOFO MEDICAL CO.,LTD
Reg #: 3045077467
·
FEI: 3045077467
·
Expires 2026
Products
17
Proprietary Names
44
Establishment Types
1
Classifications
17
Registration Details
- Registration Name
- FOFO MEDICAL CO.,LTD
- Registration Number
- 3045077467
- FEI Number
- 3045077467
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Room 1212A, No. 108 Hexiang East Road, Siming District,
- City
- Xiamen Fujian
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K091272
Owner / Operator
- Firm Name
- FOFO medical co.,ltd
- Operator Number
- 10095802
- Address
- Room 1212A, No. 108 Hexiang East Road, Siming District,
- City
- Xiamen
- State
- Fujian
- Postal Code
- 361001
- Country
- CN
- Correspondent
- Anny Ding
US Agent
- Business Name
- GVM Medical LLC
- Contact Name
- Maple Chen
- Address
- 101 Lindenwood Dr Ste 225
- City
- Malvern
- State
- PA
- ZIP
- 19355
- Country
- US
- [email protected]
- Phone
- 610 4517988
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mattress, Air Flotation, Alternating Pressure | FNM | Class 2 | General Hospital | No | 2026-05-01 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2026-05-06 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2026-05-06 |
| Bag, Urine Collection, Leg, For External Use, Non-Sterile | NNW | Class 1 | Gastroenterology, Urology | No | 2026-05-06 |
| Device, Rebreathing | BYW | Class 1 | Anesthesiology | No | 2026-05-06 |
| Helmet, Surgical | FXZ | Class 1 | General, Plastic Surgery | No | 2026-05-06 |
| Adaptor, Holder, Syringe | IQG | Class 1 | Physical Medicine | No | 2026-05-06 |
| Pump, Nebulizer, Electrically Powered | JPW | Class 1 | Ear, Nose, Throat | No | 2026-05-04 |
| Gown, Examination | FME | Class 1 | General Hospital | No | 2026-05-06 |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | Class 1 | Anesthesiology | No | 2026-05-06 |
| Catheter, Nasal, Oxygen | BZB | Class 1 | Anesthesiology | No | 2026-05-06 |
| Nebulizer (Direct Patient Interface) | CAF | Class 2 | Anesthesiology | No | 2026-05-06 |
| Support, Arm | IOY | Class 1 | Physical Medicine | No | 2026-05-06 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2026-05-04 |
| Massager, Powered Inflatable Tube | IRP | Class 2 | Physical Medicine | No | 2026-05-06 |
| Exerciser, Finger, Powered | JFA | Class 1 | Physical Medicine | No | 2026-05-06 |
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | GCX | Class 2 | General Hospital | No | 2026-05-06 |
Proprietary Names
Mattress
CUSHION, FLOTATION
Bevel Medical Cushion Flotation Mattress
Body bag
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
Urine bag
oxygen concentrator
Medical Goggles
Decompression Belt
NEBULIZER
COOL MIST COMPRESSOR
Medical Disposible protective coverall
Compressor Nebulizer (Model: BC68001, BC68002, BC6403, BC68005, BC68006)
disposable nebulizers
Nebulizer
Oxygen tube (Model: KT001)
BESMED Jet Nebulizer Bottle Set
PL-22 Shoulder Sling
DVT Air Compression Therapy System FO-3002mini
Smart-DVT
Air compression therapy system FO3002
Massage Machine, Beauty Machine
Air compression therapy systemFO3004
Air compression therapy systemFO3003
Air compression therapy systemFO3009
Smart-DVT Air Compression Therapy System FO-3002mini
Air compression therapy systemFO3007
Air compression therapy systemFO3005
Air compression therapy systemFO3006
Air compression therapy systemFO3002
Hand Rehabilitation system FO3002G
Hand Rehabilitation system FO3002H
Hsiner Jet Nebulizer
suction machine FO9001-B
suction machine FO9001-A
Air compression therapy systemFO-3001C
Air compression therapy systemFO-3001D
Air compression therapy systemFO-3008
Air compression therapy systemFO-3001E
Air compression therapy systemFO-3001
Air compression therapy systemFO-3001B
Air compression therapy systemFO-3008B
Establishment Types
Export Device to the United States But Perform No Other Operation on Device