Zhenjiang Assure Medical Equipment Co Ltd
ZHENJIANG CITY Jiangsu, CN
ZHENJIANG ASSURE MEDICAL EQUIPMENT CO LTD appears in FDA device records in ZHENJIANG CITY Jiangsu, CN. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Zhenjiang Assure Medical Equipment Co Ltd between 2012 and 2026. The busiest year on record is 2023, with 4. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2012 | 1 |
| 2023 | 4 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260319 | K5 wheelchair (16” with swing-away footrest 18” with swing-away footrest 20” with swing-away footrest 16” with elevated foot rest(ELR) 18” with elevated foot rest(ELR) 20” with elevated foot rest(ELR)) | IOR | Substantially Equivalent | |
| K251159 | Power wheelchair | ITI | Substantially Equivalent | |
| K232230 | YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE; YJ-K1F 16 NDS; YJ-K1F 18 NDE; YJ-K1F 18 NDS; YJ-K1F 20 NDE; YJ-K1F 20 NDS; YJ-K1F 18 NDEE; YJ-K1F 16 VDE; YJ-K1F 16 VDS; YJ-K1F 18 VDE; YJ-K1F 18 VDS; YJ-K1F 20 VDE; YJ-K1F 20 VDS; YJ-K2 16 VDFE; YJ-K2 16 VDFS; YJ-K2 18 VDFE; YJ-K2 18 VDFS; YJ-K2 20 VDFE; YJ-K2 20 VDFS; YJ-K1G 18 NFFE; YJ-K1G 18 NFFS; YJ-K2TC 16 NAFE; YJ-K2TC 18 NAFE; YJ-K2TC 20 NAFE) | IOR | Substantially Equivalent | |
| K232199 | Bariatric Heavy Duty Wheelchair (YJ-010B 20’’DS; YJ-010B 20’’DE; YJ-010B 20’’DFS; YJ-010B 20’’DFE;YJ-010B 20’’ADS; YJ-010B 20’’ADE; YJ-010B 20’’ADFS; YJ-010B 20’’ADFE; YJ-010B 22’’DS; YJ-010B 22’’DE; YJ-010B 22’’DFS;YJ-010B 22’’DFE; YJ-010B 22’’ADS;YJ-010B 22’’ADE; YJ-010B 22’’ADFS; YJ-010B 22’’ADFE; YJ-010B 24’’DS; YJ-010B 24’’DE; YJ-010B 24’’DFS; YJ-010B 24’’DFE; YJ-010B 24’’ADS; YJ-010B 24’’ADE; YJ-010B 22’’ADFS; YJ-010B 24’’ADFE) | IOR | Substantially Equivalent | |
| K232198 | Reclining wheelchair (YJ-011S 16”D, YJ-011S 16”DF, YJ-011S 18”D, YJ-011S 18”DF, YJ-011S 20”D, YJ-011S 20”DF) | IOR | Substantially Equivalent | |
| K231320 | Zhenjiang Assure Mechanical Wheelchair,model:K1 | IOR | Substantially Equivalent | |
| K112816 | ZHENJIANG ASURE MECHANICAL WHEELCHAIR | IOR | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007309323 | 3007309323 | ZHENJIANG ASSURE MEDICAL EQUIPMENT CO LTD | No.297/799, Chuqiao road, ZHENJIANG CITY Jiangsu 212009 CN | 2026 | and 8 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KNOAccessories, Wheelchair
- ILSAdaptor, Hygiene
- IMLArmrest, Wheelchair
- INBAttachment, Commode, Wheelchair
- IMWBrake, Extension, Wheelchair
- INMChair, With Casters
- KNNComponents, Wheelchair
- IMPCushion, Wheelchair
- IMRDevice, Anti-Tip, Wheelchair
- IMMFootrest, Wheelchair
- KIDRestraint, Wheelchair, Non-Protective
- ILISling, Arm
- FOXStand, Infusion
- INWTable, Mechanical
- INPTips And Pads, Cane, Crutch And Walker
- ITJWalker, Mechanical
- IORWheelchair, Mechanical
- ITIWheelchair, Powered
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain