FDA Registration
Active
🇨🇳 China
GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED
Reg #: 3009155917
·
FEI: 3009155917
·
Expires 2026
Products
6
Proprietary Names
21
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED
- Registration Number
- 3009155917
- FEI Number
- 3009155917
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No. 5, the Second Industrial Zone, Zhukeng Community, Longtian Street, Pingshan District
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K171379
Owner / Operator
- Firm Name
- Grandway Technology (Shenzhen) Limited
- Operator Number
- 10036359
- Address
- No. 5, the Second Industrial Zone, Zhukeng Community, Longtian Street, Pingshan District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518118
- Country
- CN
- Correspondent
- Patrick Chow
US Agent
- Business Name
- IRC USA
- Contact Name
- Charles Mack
- Address
- 2950 E Lindrick Dr.
- City
- Chandler
- State
- AZ
- ZIP
- 85249
- Country
- US
- [email protected]
- Phone
- 931 6254938
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sleeve, Limb, Compressible | JOW | Class 2 | Cardiovascular | No | 2025-09-28 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2020-12-07 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2019-04-15 |
| Massager, Powered Inflatable Tube | IRP | Class 2 | Physical Medicine | No | 2025-07-09 |
| Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat | PFW | Class 2 | Physical Medicine | No | 2025-09-28 |
| Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | IMI | Class 2 | Physical Medicine | No | 2025-09-28 |
Proprietary Names
MD2220, MD2222, MD2223, MD2230, MD2231, MD2232
MD2200
MD2210
Grandway - MD5681
MD5990
MD5940
MD6290
MD5960
BP11G
MD5451
BM54
MD41A0
MD6300
MD47A1
AFIB-4/0148
MD1801, MD1811, MD1821, MD1831, MD1841, MD1851, MD1861, MD1871
MD1800, MD1810, MD1820, MD1830, MD1840, MD1850, MD1860, MD1870
MD1500, MD1520, MD1530, MD1560, MD1590
MD1100, MD1110, MD1130, MD1150, MD1160, MD1180
MD3100, MD3110, MD3120, MD3130, MD3140, MD3150, MD3101, MD3111, MD3121, MD3131, MD3141, MD3151
MD3000, MD3010, MD3020, MD3030, MD3040, MD3050, MD3001, MD3011, MD3021, MD3031, MD3041, MD3051
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device