FDA Registration
Active
🇭🇰 Hong Kong
HEALTHCARE TECHNOLOGY INTERNATIONAL LTD.
Reg #: 3008959444
·
FEI: 3008959444
·
Expires 2026
Products
16
Proprietary Names
10
Establishment Types
1
Classifications
16
Registration Details
- Registration Name
- HEALTHCARE TECHNOLOGY INTERNATIONAL LTD.
- Registration Number
- 3008959444
- FEI Number
- 3008959444
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Units 15-21, 12/F, Topsail Plaza,, 11 On Sum Street,
- City
- Shek Mun, Shatin
- Country
- HK
Regulatory Submissions
- 510(k) Number
- K233732
Owner / Operator
- Firm Name
- HEALTHCARE TECHNOLOGY INTERNATIONAL LTD.
- Operator Number
- 9058334
- Address
- Units 15-21, 12/F, Topsail Plaza,, 11 On Sum Street,
- City
- Shek Mun, Shatin
- State
- HK-NOTA
- Postal Code
- --
- Country
- HK
US Agent
- Business Name
- Law Offices Of Albert Wai-Kit Chan
- Contact Name
- Albert Wai-Kit Chan
- Address
- Law Offices Of Albert Wai-Kit Chan, PLLC World Plaza, Suite 604 141-07 20th Avenue
- City
- Whitestone
- State
- NY
- ZIP
- 11357
- Country
- US
- [email protected]
- Phone
- 718 7991000
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2019-01-04 |
| Dermal Cooling Pack/Vacuum/Massager | OOK | Class 2 | General, Plastic Surgery | No | 2026-01-06 |
| Pad, Heating, Powered | IRT | Class 2 | Physical Medicine | No | 2023-08-10 |
| Warmer, Thermal, Infusion Fluid | LGZ | Class 2 | General Hospital | No | 2012-07-03 |
| Massager, Powered Inflatable Tube | IRP | Class 2 | Physical Medicine | No | 2018-10-07 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2018-10-07 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2014-08-27 |
| Intra-Abdominal Pressure Monitoring Device | PHU | Class U | Unknown | No | 2020-01-06 |
| Uroflowmeter | EXY | Class 2 | Gastroenterology, Urology | No | 2020-01-06 |
| Catheter, Retention Type, Balloon | EZL | Class 2 | Gastroenterology, Urology | No | 2020-01-06 |
| Device, Pressure Applying | KNM | Class 1 | Physical Medicine | No | 2022-06-17 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2026-05-12 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2023-08-03 |
| Oximeter, Wellness | PGJ | Class 2 | Cardiovascular | No | 2023-08-14 |
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2023-02-28 |
| Enzymatic Esterase--Oxidase, Cholesterol | CHH | Class 1 | Clinical Chemistry | No | 2009-05-21 |
Proprietary Names
G3PRO
Theragun Pro
Theragun Elite
Theragun Prime Plus
Theragun PRO PLUS
Accuryn Monitoring System; Accuryn SmartFoley IAP UO Temp Tray System; Accuryn SmartFoley UO Temp Tray System
Accuryn SmartFoley IAP UO Temp Tray System
Accuryn SmartFoley UO Temp Tray System
AccuTab
Accuryn Monitoring System
Establishment Types
Export Device to the United States But Perform No Other Operation on Device