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FDA 510(k)

Zhenjiang Assure Mechanical Wheelchair,model:K1

K-Number: K231320 · 2023-06-05

ApplicantZhenjiang Assure Medical Equipment Co., Ltd.
Decision Date2023-06-05
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Zhenjiang Assure Mechanical Wheelchair,model:K1 is a medical device manufactured by Zhenjiang Assure Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2023-06-05 under approval number K231320. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Zhenjiang Assure Mechanical Wheelchair,model:K1?

Zhenjiang Assure Mechanical Wheelchair,model:K1 is a medical device that received FDA 510(k) clearance on 2023-06-05. It is manufactured by Zhenjiang Assure Medical Equipment Co., Ltd.. The 510(k) number is K231320.

When was Zhenjiang Assure Mechanical Wheelchair,model:K1 approved by the FDA?

Zhenjiang Assure Mechanical Wheelchair,model:K1 received FDA 510(k) clearance on 2023-06-05, under approval number K231320.

What company makes Zhenjiang Assure Mechanical Wheelchair,model:K1?

Zhenjiang Assure Mechanical Wheelchair,model:K1 is manufactured by Zhenjiang Assure Medical Equipment Co., Ltd..

What is the FDA product code for Zhenjiang Assure Mechanical Wheelchair,model:K1?

The FDA product code for Zhenjiang Assure Mechanical Wheelchair,model:K1 is IOR.

Related Clinical Trials

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Related PubMed Literature

PMID: 38493931 Establishing finite element model credibility of a pedicle screw system under compression-bending: An end-to-end example of the ASME V&V 40 standard. Methods (San Diego, Calif.) (2024)

Other Devices by Zhenjiang Assure Medical Equipment Co., Ltd.

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) K232199Bariatric 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) K232198Reclining 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) K251159Power wheelchair 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))

Related Devices (Code: IOR)

K162696Kuschall Advance Manual WheelchairInvacare Corporation K162686Kuschall Champion Manual WheelchairInvacare Corporation K162692Kuschall K-Series Attract Manual WheelchairInvacare Corporation K161425APEX Manual WheelchairMotion Composites K153328SUNCO Mechanical Wheelchair, model SKW-9003Danyang Sunco Machinery Co., Ltd. K151492KuduR82 A/S

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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