Medical Device Manufacturer · TW , Hsin Chu City

Zhenjiang Assure Medical Equipment Co., Ltd.

6 submissions · 6 cleared · Since 2012

6

Total

6

Cleared

0

Denied

Zhenjiang Assure Medical Equipment Co., Ltd. — FDA 510(k) Submissions

Zhenjiang Assure Medical Equipment Co., Ltd. has submitted 6 FDA 510(k) premarket notifications since 2012, of which 6 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Wheelchair, Mechanical, Wheelchair, Powered . Use the specialty filter in the sidebar to narrow results.

6 devices

1–6 of 6

Power wheelchair

K251159 · ITI Wheelchair, Powered · Physical Medicine

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)

K232230 · IOR Wheelchair, Mechanical · Physical Medicine

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)

K232198 · IOR Wheelchair, Mechanical · Physical Medicine

Bariatric Heavy Duty Wheelchair (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 22??ADFS; YJ-010B 24??ADFE)

K232199 · IOR Wheelchair, Mechanical · Physical Medicine

Zhenjiang Assure Mechanical Wheelchair,model:K1

K231320 · IOR Wheelchair, Mechanical · Physical Medicine

ZHENJIANG ASURE MECHANICAL WHEELCHAIR

K112816 · IOR Wheelchair, Mechanical · Physical Medicine

Data Source

FDA 510(k) public files . 174,402 total devices indexed.