Bariatric Heavy Duty Wheelchair (YJ-010B 20DS +23 more— 510(k) K232199

Clearance details

Device name as filed

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)

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

2023-07-25

Decision date

2023-09-15

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Zhenjiang, CN

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• K232230 — YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE +23 more2023-10-03
• K232198 — Reclining wheelchair (YJ-011S 16D, YJ-011S 16DF, YJ-011S 18D, YJ-011S 18DF, YJ-011S 20D, YJ-011S 20DF)2023-09-15
• 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 →