FDA 510(k)

Reclining wheelchair (YJ-013L)

K-번호: K260144 · 2026-09-15

신청자Zhenjiang Assure Medical Equipment Co., Ltd.

결정일2026-09-15

제품 코드IOR

자문 위원회PM

결정Substantially Equivalent

기기 요약

Reclining wheelchair (YJ-013L) is the device name listed in this FDA 510(k) record. The listed applicant is Zhenjiang Assure Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2026-09-15 under 510(k) number K260144. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Reclining wheelchair (YJ-013L)?

Reclining wheelchair (YJ-013L) is a medical device that received FDA 510(k) clearance on 2026-09-15. The listed applicant is Zhenjiang Assure Medical Equipment Co., Ltd.. The 510(k) number is K260144.

When did Reclining wheelchair (YJ-013L) receive FDA 510(k) clearance?

Reclining wheelchair (YJ-013L) received FDA 510(k) clearance on 2026-09-15, under 510(k) number K260144.

Who is the listed applicant for Reclining wheelchair (YJ-013L)?

The FDA 510(k) record lists Zhenjiang Assure Medical Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Reclining wheelchair (YJ-013L)?

The FDA product code for Reclining wheelchair (YJ-013L) is IOR.

Zhenjiang Assure Medical Equipment Co., Ltd.를 신청인으로 등재한 기타 기록

K261919Multifunctional wheelchair (YJ-059)K260145YJ-K1K2 Wheelchair (YJ-013F)K260141Bariatric Heavy Duty Wheelchair (YJ-010V, YJ-010C)K260319K5 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))K251159Power wheelchair K232230YJ-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)

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