Aikin Healthcare Co., Ltd.
Registered establishment in Kunshan, Jiangsu, China. 21 device types, 1 clearance.
Aikin Healthcare Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Cane, Crutch and 19 other device types. Its earliest product listing with the FDA dates from 2022.
21device types registered with the FDA
1510(k) clearance
Registration
| Registered name | Aikin Healthcare Co., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3007499787 |
| FEI number | 3007499787 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 昆山市爱新康复器材有限公司 |
|---|---|
| Source | Qichacha company register |
Location
| City | Kunshan |
|---|---|
| Province | Jiangsu |
| Address | 178 Kang Zhuang Rd. |
| Postal code | 215314 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessories, Wheelchair | Class 1 | ACCESSORIES, WHEELCHAIR, OXYGEN HOLDER, CANE & CRUTCH HOLDER (PLASTIC) tray table of wheelchair | 2022 | 80 |
| Adaptor, Hygiene | Class 1 | Adaptor, Hygiene, Toilet Seat, Toilet Safety Frame | 2022 | 193 |
| Aid, Transfer | Class 1 | AID, Transfer, Bath Bench, Shower Chair, Foot Stool TUB Rall, Grab BAR | 2022 | 118 |
| Armrest, Wheelchair | Class 1 | Armrest, Wheelchair | 2022 | 29 |
| Attachment, Commode, Wheelchair | Class 1 | Attachment, Commode, Wheelchair | 2022 | 70 |
| Belt, Wheelchair | Class 1 | Wheelchair Belt | 2024 | 24 |
| Board, Lap, Wheelchair | Class 1 | Lap Board | 2024 | 14 |
| Brake, Extension, Wheelchair | Class 1 | Brake, Extension, Wheelchair | 2022 | 19 |
| Cane | Class 1 | Cane | 2022 | 97 |
| Cart, Emergency, Cardiopulmonary (Excluding Equipment) | Class 1 | Cart, Emergency, Cardiopulmonary (Excluding Equipment), E-Rack, Oxygen Cart, Oxygen BAG, Nebulizer BAG | 2022 | 34 |
| Chair, Adjustable, Mechanical | Class 1 | Chair, Adjustable, Mechanical | 2022 | 46 |
| Components, Wheelchair | Class 1 | COMPONENTS, Stump support WHEELCHAIR,WHEELCHAIR PARTS | 2022 | 54 |
| Crutch | Class 1 | Crutch | 2022 | 112 |
| Device, Anti-Tip, Wheelchair | Class 1 | Device, Anti-TIP, Wheelchair | 2022 | 22 |
| Exerciser, Non-Measuring | Class 1 | Manual Pedal Exerciser, Exerciser, Non-measuring | 2022 | 82 |
| Footrest, Wheelchair | Class 1 | Footrest, Wheelchair | 2022 | 25 |
| Handrim, Wheelchair | Class 1 | Handrim, Wheelchair | 2022 | 12 |
| Stand, Infusion | Class 1 | Stand, Infusion, IV Pole | 2022 | 75 |
| Table, Mechanical | Class 1 | Table, Mechanical | 2022 | 46 |
| Walker, Mechanical | Class 1 | Walker, Mechanical Rollator, Walker Wheel | 2022 | 183 |
| Wheelchair, Mechanical | Class 1 | Wheelchair, Mechanical | 2022 | 46 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K120032 | 2012-04-13 | IOR | Traditional | This company |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.