YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE +23 more— 510(k) K232230

Clearance details

Device name as filed

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)

Applicant

Zhenjiang Assure Medical Equipment Co., Ltd.

Product code

Code IOR

Device class

Class 1

Regulation

21 CFR 890.3850

Advisory panel

Physical Medicine

Date received

2023-07-27

Decision date

2023-10-03

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Zhenjiang City, CN

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• K261075 — Manual Wheelchair (MS01); Manual Wheelchair (MA01)2026-06-22
• K261076 — Caregiver-assisted wheelchair (MS02); Caregiver-assisted wheelchair (MA02)2026-06-22
• K260849 — ICON 35; ICON 45; ICON 60; ICON 30FAF2026-06-11

• 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))2026-03-31
• K251159 — Power wheelchair2025-12-22
• K232198 — Reclining wheelchair (YJ-011S 16D, YJ-011S 16DF, YJ-011S 18D, YJ-011S 18DF, YJ-011S 20D, YJ-011S 20DF)2023-09-15
• K232199 — Bariatric Heavy Duty Wheelchair (YJ-010B 20DS +23 more2023-09-15
• K231320 — Zhenjiang Assure Mechanical Wheelchair,model:K12023-06-05

Death

10

Injury

232

Other

2

Total

244

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →