FDA Registration
Active
🇨🇳 China
DOUBLE CARE MEDICAL TECHNOLOGY CO.,LTD.
Reg #: 3009282549
·
FEI: 3009282549
·
Expires 2026
Products
19
Proprietary Names
34
Establishment Types
2
Classifications
19
Registration Details
- Registration Name
- DOUBLE CARE MEDICAL TECHNOLOGY CO.,LTD.
- Registration Number
- 3009282549
- FEI Number
- 3009282549
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Second Street Yongshi Blvd, Shiwan Boluo guangdong
- City
- Liwu Shiwan Boluo Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K915262
Owner / Operator
- Firm Name
- DOUBLE CARE MEDICAL TECHNOLOGY CO.,LTD.
- Operator Number
- 10038725
- Address
- Second Street Yongshi Blvd, Shiwan Boluo guangdong
- City
- Liwu Shiwan Boluo
- State
- Guangdong
- Postal Code
- None
- Country
- CN
US Agent
- Business Name
- Regulatory Insight, Inc.
- Contact Name
- Kevin Walls
- Address
- 33 Golden Eagle Lane
- City
- Littleton
- State
- CO
- ZIP
- 80127
- Country
- US
- [email protected]
- Phone
- 720 9625412
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2020-04-06 |
| Bed, Manual | FNJ | Class 1 | General Hospital | No | 2011-11-07 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-04-06 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2025-04-17 |
| Walker, Mechanical | ITJ | Class 1 | Physical Medicine | No | 2011-11-07 |
| Stand, Infusion | FOX | Class 1 | General Hospital | No | 2011-11-07 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2021-04-02 |
| Cap, Surgical | FYF | Class 1 | General, Plastic Surgery | No | 2020-04-06 |
| Exerciser, Non-Measuring | ION | Class 1 | Physical Medicine | No | 2014-11-19 |
| Tips And Pads, Cane, Crutch And Walker | INP | Class 1 | Physical Medicine | No | 2016-02-22 |
| Chair And Table, Medical | KMN | Class 1 | General Hospital | No | 2011-11-07 |
| Adaptor, Hygiene | ILS | Class 1 | Physical Medicine | No | 2011-11-07 |
| Aid, Transfer | IKX | Class 1 | Physical Medicine | No | 2011-11-07 |
| Crutch | IPR | Class 1 | Physical Medicine | No | 2011-11-07 |
| Wheelchair, Mechanical | IOR | Class 1 | Physical Medicine | No | 2011-11-07 |
| Stocking, Medical Support (For General Medical Purposes) | FQL | Class 1 | General Hospital | No | 2014-08-13 |
| Chair, With Casters | INM | Class 1 | Physical Medicine | No | 2011-11-07 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2014-11-12 |
| Cane | IPS | Class 1 | Physical Medicine | No | 2011-11-07 |
Proprietary Names
Non-surgical isolation gown
Bed rail
Manual bed
Face Shield
Disposable Medical Mask
Ice Bag
Walker
Rollator
IV Pole
Resting Hand Splint, Brace
Surgical Cap
Pedal Exerciser
MEDICAL DEPOT d/b/a Drive DeVilbiss Healthcare
Showerbuddy LLC
ALEX ORTHOPEDIC, INC.
PCP CHAMPION
Replacement Foam Grip, Black
Wooden Bed and Lap Tray
Over bed table
Commode
Toilet seat
Extendable Back Scratcher,Blue
Extendable Back Scratcher,Black
Extendable Back Scratcher,Pink
Bath bench
Rubber Bath Mat Small 70cm X 40cm White
Grab bar
Bath rail
Crutch
Wheelchair
Stocking Socks
Transport chair
CPR mask
Cane
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device