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FDA 510(k)

Electric Wheelchair, Model: 9000N

K-Number: K221799 · 2022-09-16

ApplicantSilver Fox Corporation Limited
Decision Date2022-09-16
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Electric Wheelchair, Model: 9000N is the device name listed in this FDA 510(k) record. The listed applicant is Silver Fox Corporation Limited. It received FDA 510(k) clearance on 2022-09-16 under 510(k) number K221799. 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 Electric Wheelchair, Model: 9000N?

Electric Wheelchair, Model: 9000N is a medical device that received FDA 510(k) clearance on 2022-09-16. The listed applicant is Silver Fox Corporation Limited. The 510(k) number is K221799.

When did Electric Wheelchair, Model: 9000N receive FDA 510(k) clearance?

Electric Wheelchair, Model: 9000N received FDA 510(k) clearance on 2022-09-16, under 510(k) number K221799.

Who is the listed applicant for Electric Wheelchair, Model: 9000N?

The FDA 510(k) record lists Silver Fox Corporation Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Electric Wheelchair, Model: 9000N?

The FDA product code for Electric Wheelchair, Model: 9000N is ITI.

Related Devices (Code: ITI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261149Electric Wheelchair (DY611A-2, DY612A-1)Zhejiang Lumbre Electric Appliance Co., Ltd.K261396Electric WheelchairNingbo Resshidi Medical Devices Co., Ltd.K261164Electric wheelchair (XW-LY007 )Yongkang Ruihe Metal Product Co., Ltd.K260937Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK)Shanghai Waylong Intelligent Technology Co.,LtdK253812Power Wheelchair (W5915B, W5915C, W5915D)Zhejiang Innuovo Rehabilitation Devices Co.,LtdK260335Electric Wheelchair (S500-6)Zhongshan Sulenz Intelligent Technology Co., Ltd.

Official Source

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

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