FDA Registration
Active
🇹🇼 Taiwan
HEARTWAY MEDICAL PRODUCTS CO., LTD.
Reg #: 9616881
·
FEI: 3002847480
·
Expires 2026
Products
11
Proprietary Names
20
Establishment Types
2
Classifications
11
Registration Details
- Registration Name
- HEARTWAY MEDICAL PRODUCTS CO., LTD.
- Registration Number
- 9616881
- FEI Number
- 3002847480
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No. 6, Gongyequ 25th Rd., Baoshan Vil., Nantun Dist.,
- City
- TAICHUNG CITY
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K973491
Owner / Operator
- Firm Name
- HEARTWAY MEDICAL PRODUCTS CO., LTD.
- Operator Number
- 9030564
- Address
- No. 6, Gongyequ 25th Rd., Baoshan Vil., Nantun Dist.,
- City
- Taichung City
- State
- TW-TXG
- Postal Code
- 408017
- Country
- TW
US Agent
- Business Name
- ROC Chinese-European Industrial Research Society
- Contact Name
- Shu-Chen Cheng
- Address
- 2064 Tamarin Dr
- City
- Columbus
- State
- OH
- ZIP
- 43235
- Country
- US
- [email protected]
- Phone
- 614 5888168
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Wheelchair, Mechanical | IOR | Class 1 | Physical Medicine | No | 2007-11-28 |
| Vehicle, Motorized 3-Wheeled | INI | Class 2 | Physical Medicine | No | 2012-11-13 |
| Footrest, Wheelchair | IMM | Class 1 | Physical Medicine | No | 1998-01-21 |
| Wheelchair, Powered | ITI | Class 2 | Physical Medicine | No | 2015-03-12 |
| Device, Anti-Tip, Wheelchair | IMR | Class 1 | Physical Medicine | No | 1998-01-21 |
| Armrest, Wheelchair | IML | Class 1 | Physical Medicine | No | 1998-01-21 |
| Holder, Crutch And Cane, Wheelchair | IMZ | Class 1 | Physical Medicine | No | 1998-01-21 |
| Components, Wheelchair | KNN | Class 1 | Physical Medicine | No | 1998-01-21 |
| Accessories, Wheelchair | KNO | Class 1 | Physical Medicine | No | 1998-01-21 |
| Brake, Extension, Wheelchair | IMW | Class 1 | Physical Medicine | No | 1998-01-21 |
| Handrim, Wheelchair | IMO | Class 1 | Physical Medicine | No | 1998-01-21 |
Proprietary Names
HEARTWAY
Heartway Scooter, S34
Heartway
HEARTWAY Electrically Powered Wheelchair, Model P19
BRIO S19 Scooter
Cute Mini S16 Scooter
Heartway S8 Power Mobility Scooter
Heartway Scooter, S11
HEARTWAY HP6
Heartway Powered Wheelchair, P23
PF2
HEARTWAY Power Mobility Scooter, model S15
PF6
Heartway S9 Power Mobility Scooter
Heartway S12 Power Mobility Scooter
HEARTWAY Auto Folding Scooter, S21F
HP4
HEARTWAY Power Mobility Scooter, Cutie S17
HEARTWAY Electrically Powered Wheelchair P27
HEARTWAY Power Wheelchair, model P25
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device