Zhenjiang Assure Medical Equipment Co., Ltd.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Zhenjiang Assure Medical Equipment Co., Ltd.” (first 2012, latest 2026), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 99 days. Since 2017 the median was 84 days, against 122 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 203 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 4 | 52 |
| 2024 | 0 | — |
| 2025 | 1 | 251 |
| 2026 | 5 | 238 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Zhenjiang Assure Medical Equipment Co., Ltd. took a median 84 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 122 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IOR | Wheelchair, Mechanical | 10 | 10 |
| ITI | Wheelchair, Powered | 1 | 1 |
Review panels
- Physical Medicine (11)
Most recent Zhenjiang Assure Medical Equipment Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261919 | Multifunctional wheelchair (YJ-059) | IOR | 2026-09-16 | 99 |
| K260145 | YJ-K1K2 Wheelchair (YJ-013F) | IOR | 2026-09-15 | 238 |
| K260144 | Reclining wheelchair (YJ-013L) | IOR | 2026-09-15 | 238 |
| K260141 | Bariatric Heavy Duty Wheelchair (YJ-010V, YJ-010C) | IOR | 2026-09-15 | 238 |
| 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 | 2026-03-31 | 60 |
| K251159 | Power wheelchair | ITI | 2025-12-22 | 251 |
| 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 | 2023-10-03 | 68 |
| K232199 | Bariatric Heavy Duty Wheelchair (YJ-010B 20DS; YJ-010B 20DE; YJ-010B 20DFS; YJ-010B 20DFE;YJ-010B 20ADS; YJ-010B 20ADE; YJ-010B 20ADFS; YJ-010B 20ADFE; YJ-010B 22DS; YJ-010B 22DE; YJ-010B 22DFS;YJ-010B 22DFE; YJ-010B 22ADS;YJ-010B 22ADE; YJ-010B 22ADFS; YJ-010B 22ADFE; YJ-010B 24DS; YJ-010B 24DE; YJ-010B 24DFS; YJ-010B 24DFE; YJ-010B 24ADS; YJ-010B 24ADE; YJ-010B 22ADFS; YJ-010B 24ADFE) | IOR | 2023-09-15 | 52 |
| K232198 | Reclining wheelchair (YJ-011S 16D, YJ-011S 16DF, YJ-011S 18D, YJ-011S 18DF, YJ-011S 20D, YJ-011S 20DF) | IOR | 2023-09-15 | 52 |
| K231320 | Zhenjiang Assure Mechanical Wheelchair,model:K1 | IOR | 2023-06-05 | 28 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Zhenjiang Assure Medical Equipment Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Zhenjiang Huayang Latex Products Co., Ltd. (1 510(k)s)
- Zhenjiang Suhui Latex Products Co., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Zhenjiang Assure Medical Equipment Co., Ltd.?
FDA lists 11 510(k) clearances under the applicant name “Zhenjiang Assure Medical Equipment Co., Ltd.” (first 2012, latest 2026), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Zhenjiang Assure Medical Equipment Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Zhenjiang Assure Medical Equipment Co., Ltd. is 99 days. Since 2017: 84 days, versus 122 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Zhenjiang Assure Medical Equipment Co., Ltd.?
The most frequent FDA product codes under this applicant name are IOR (Wheelchair, Mechanical, 10); ITI (Wheelchair, Powered, 1).
Next steps
- See all 11 Zhenjiang Assure Medical Equipment Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code IOR, Zhenjiang Assure Medical Equipment Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.