Zhenjiang Assure Medical Equipment Co., Ltd.
FDA 510(k) & PMA Approved 기기 — 10 products
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총 기기 수10
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최신 FDA 결정
| 유형 | 번호 | 기기명 | 코드 | 날짜 | 작업 |
|---|---|---|---|---|---|
| 510(k) | K261919 | Multifunctional wheelchair (YJ-059) | IOR | 2026-09-16 | 보기 |
| 510(k) | K260144 | Reclining wheelchair (YJ-013L) | IOR | 2026-09-15 | 보기 |
| 510(k) | K260145 | YJ-K1K2 Wheelchair (YJ-013F) | IOR | 2026-09-15 | 보기 |
| 510(k) | K260141 | 비만용 강력한 휠체어 (YJ-010V, YJ-010C) | IOR | 2026-09-15 | 보기 |
| 510(k) | 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 | 보기 |
| 510(k) | K251159 | Power wheelchair | ITI | 2025-12-22 | 보기 |
| 510(k) | 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 | 보기 |
| 510(k) | 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 | 2023-09-15 | 보기 |
| 510(k) | K232199 | 비만용 강력한 휠체어 (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 24’’ADFS; YJ-010B 24’’ADFE) | IOR | 2023-09-15 | 보기 |
| 510(k) | K231320 | Zhenjiang Assure Mechanical Wheelchair,model:K1 | IOR | 2023-06-05 | 보기 |
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