FDA Registration
Active
🇨🇳 China
JIANGSU ASSURE MEDICAL EQUIPMENT CO., LTD
Reg #: 3033814356
·
FEI: 3033814356
·
Expires 2026
Products
18
Proprietary Names
10
Establishment Types
2
Classifications
18
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Registration Details
- Registration Name
- JIANGSU ASSURE MEDICAL EQUIPMENT CO., LTD
- Registration Number
- 3033814356
- FEI Number
- 3033814356
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No. 799, CHUQIAO ROAD, NO.39, Hengtong Road
- City
- ZHENJIANG CITY Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K232199
Owner / Operator
- Firm Name
- JIANGSU ASSURE MEDICAL EQUIPMENT CO LTD
- Operator Number
- 10091590
- Address
- No. 799, CHUQIAO ROAD
- City
- ZHENJIANG CITY
- State
- Jiangsu
- Postal Code
- 212009
- Country
- CN
- Correspondent
- BRUCE XIE
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Wheelchair, Mechanical | IOR | Class 1 | Physical Medicine | No | 2025-09-03 |
| Belt, Wheelchair | IQB | Class 1 | Physical Medicine | No | 2026-06-01 |
| Components, Wheelchair | KNN | Class 1 | Physical Medicine | No | 2024-10-24 |
| Restraint, Wheelchair, Non-Protective | KID | Class 1 | Physical Medicine | No | 2024-10-24 |
| Armrest, Wheelchair | IML | Class 1 | Physical Medicine | No | 2024-10-17 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 2025-12-13 |
| Stand, Infusion | FOX | Class 1 | General Hospital | No | 2024-10-24 |
| Cushion, Wheelchair | IMP | Class 1 | Physical Medicine | No | 2024-10-24 |
| Tips And Pads, Cane, Crutch And Walker | INP | Class 1 | Physical Medicine | No | 2024-10-24 |
| Accessories, Wheelchair | KNO | Class 1 | Physical Medicine | No | 2024-10-24 |
| Device, Anti-Tip, Wheelchair | IMR | Class 1 | Physical Medicine | No | 2024-10-24 |
| Brake, Extension, Wheelchair | IMW | Class 1 | Physical Medicine | No | 2024-10-24 |
| Footrest, Wheelchair | IMM | Class 1 | Physical Medicine | No | 2024-10-24 |
| Attachment, Commode, Wheelchair | INB | Class 1 | Physical Medicine | No | 2024-10-24 |
| Chair, With Casters | INM | Class 1 | Physical Medicine | No | 2024-10-24 |
| Adaptor, Hygiene | ILS | Class 1 | Physical Medicine | No | 2024-10-24 |
| Table, Mechanical | INW | Class 1 | Physical Medicine | No | 2024-10-24 |
| Walker, Mechanical | ITJ | Class 1 | Physical Medicine | No | 2024-10-24 |
Proprietary Names
Safety belt
Guardian Reclining wheelchair Medline Industries, LP
ASSURE
guardian pediatric wheelchair Medline Industries, LP
Bariatric Heavy duty wheelchair
Reclining wheelchair
Medical Depot Inc
Guardian K3 Wheelchair, Guardian Wheelchair Extra Wide, Guardian K3 Wheelchair Plus, Guardian K4 Wheelchair, Walgreens K
Medline K5166N21E1 K5166N21S1 K5186N21E1 K5186N21S1 K5206N21E1 K5206N21S1
K5
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device