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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Mechanical
510(k) Number K232230
Device Name 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.
# 297, Chuqiao Rd.
Zhenjiang City,  CN
Applicant Contact Ying Mei
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
Rm. 1401, Dongfang Bldg.,
1500# Century Ave.
Shanghai,  CN 200122
Correspondent Contact Eva Li
Regulation Number890.3850
Classification Product Code
IOR  
Date Received07/27/2023
Decision Date 10/03/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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