FDA Registration
Active
🇨🇳 China
Aikin Healthcare Co., LTD
Reg #: 3007499787
·
FEI: 3007499787
·
Expires 2026
Products
21
Proprietary Names
22
Establishment Types
2
Classifications
21
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Registration Details
- Registration Name
- Aikin Healthcare Co., LTD
- Registration Number
- 3007499787
- FEI Number
- 3007499787
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 178 Kang Zhuang Rd., Zhou Shi Zhen
- City
- Kunshan Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K120032
Owner / Operator
- Firm Name
- AHT Enterprise Corporation
- Operator Number
- 10085047
- Address
- Vistra Corporate Services Centre, G/Floor NPF Building Beach Rd
- City
- Apia
- State
- Tuamasaga
- Postal Code
- 96799
- Country
- WS
- Correspondent
- Shun-Hui Fan
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 |
|---|---|---|---|---|---|
| Walker, Mechanical | ITJ | Class 1 | Physical Medicine | No | 2022-06-23 |
| Attachment, Commode, Wheelchair | INB | Class 1 | Physical Medicine | No | 2022-06-23 |
| Chair, Adjustable, Mechanical | INN | Class 1 | Physical Medicine | No | 2022-06-23 |
| Accessories, Wheelchair | KNO | Class 1 | Physical Medicine | No | 2022-06-23 |
| Exerciser, Non-Measuring | ION | Class 1 | Physical Medicine | No | 2022-04-28 |
| Cane | IPS | Class 1 | Physical Medicine | No | 2022-06-23 |
| Armrest, Wheelchair | IML | Class 1 | Physical Medicine | No | 2022-06-23 |
| Handrim, Wheelchair | IMO | Class 1 | Physical Medicine | No | 2022-06-23 |
| Crutch | IPR | Class 1 | Physical Medicine | No | 2022-06-23 |
| Brake, Extension, Wheelchair | IMW | Class 1 | Physical Medicine | No | 2022-06-23 |
| Footrest, Wheelchair | IMM | Class 1 | Physical Medicine | No | 2022-06-23 |
| Cart, Emergency, Cardiopulmonary (Excluding Equipment) | BZN | Class 1 | Anesthesiology | No | 2022-06-23 |
| Stand, Infusion | FOX | Class 1 | General Hospital | No | 2022-06-23 |
| Wheelchair, Mechanical | IOR | Class 1 | Physical Medicine | No | 2022-06-23 |
| Device, Anti-Tip, Wheelchair | IMR | Class 1 | Physical Medicine | No | 2022-06-23 |
| Board, Lap, Wheelchair | IMX | Class 1 | Physical Medicine | No | 2024-01-24 |
| Adaptor, Hygiene | ILS | Class 1 | Physical Medicine | No | 2022-06-23 |
| Table, Mechanical | INW | Class 1 | Physical Medicine | No | 2022-06-23 |
| Belt, Wheelchair | IQB | Class 1 | Physical Medicine | No | 2024-01-24 |
| Aid, Transfer | IKX | Class 1 | Physical Medicine | No | 2022-06-23 |
| Components, Wheelchair | KNN | Class 1 | Physical Medicine | No | 2022-06-23 |
Proprietary Names
WALKER, MECHANICAL ROLLATOR, WALKER WHEEL
ATTACHMENT, COMMODE, WHEELCHAIR
CHAIR, ADJUSTABLE, MECHANICAL
ACCESSORIES, WHEELCHAIR, OXYGEN HOLDER, CANE & CRUTCH HOLDER (PLASTIC) tray table of wheelchair
Exerciser, Non-measuring
Manual Pedal Exerciser
CANE
ARMREST, WHEELCHAIR
HANDRIM, WHEELCHAIR
CRUTCH
BRAKE, EXTENSION, WHEELCHAIR
FOOTREST, WHEELCHAIR
CART, EMERGENCY, CARDIOPULMONARY (EXCLUDING EQUIPMENT), E-RACK, OXYGEN CART, OXYGEN BAG, NEBULIZER BAG
STAND, INFUSION , IV POLE
WHEELCHAIR, MECHANICAL
DEVICE, ANTI-TIP, WHEELCHAIR
Lap Board
ADAPTOR, HYGIENE, TOILET SEAT, TOILET SAFETY FRAME
TABLE, MECHANICAL
Wheelchair Belt
AID, TRANSFER , BATH BENCH, SHOWER CHAIR, FOOT STOOL TUB RALL, GRAB BAR
COMPONENTS, Stump support WHEELCHAIR,WHEELCHAIR PARTS
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)