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FDA 510(k)

Power wheelchair

K-Number: K251159 · 2025-12-22

ApplicantZhenjiang Assure Medical Equipment Co., Ltd.
Decision Date2025-12-22
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Power wheelchair is a medical device manufactured by Zhenjiang Assure Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2025-12-22 under approval number K251159. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Power wheelchair?

Power wheelchair is a medical device that received FDA 510(k) clearance on 2025-12-22. It is manufactured by Zhenjiang Assure Medical Equipment Co., Ltd.. The 510(k) number is K251159.

When was Power wheelchair approved by the FDA?

Power wheelchair received FDA 510(k) clearance on 2025-12-22, under approval number K251159.

What company makes Power wheelchair?

Power wheelchair is manufactured by Zhenjiang Assure Medical Equipment Co., Ltd..

What is the FDA product code for Power wheelchair?

The FDA product code for Power wheelchair is ITI.

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) K231320Zhenjiang Assure Mechanical Wheelchair,model:K1 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: ITI)

K161241e-fix E35/E36Alber GmbH K153636Liberator Powered Wheelchair with Solar CompanionSolar Mobilityllc K160031Quickie Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) and Zippie ZM-310 (Models BC, SC)Sunrise Medical (Us), LLC K151717twionAlber GmbH K153543WHILL Model MWhill, Inc. K152672Cajun Commando 4x4Lil Critter, LLC

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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