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FDA 510(k)

Powered Wheelchair DYW30A(D09)

K-Number: K170787 · 2017-08-09

ApplicantNanjing Jin Bai HE Medical Apparatus Co., Ltd.
Decision Date2017-08-09
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Powered Wheelchair DYW30A(D09) is the device name listed in this FDA 510(k) record. The listed applicant is Nanjing Jin Bai HE Medical Apparatus Co., Ltd.. It received FDA 510(k) clearance on 2017-08-09 under 510(k) number K170787. 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 Powered Wheelchair DYW30A(D09)?

Powered Wheelchair DYW30A(D09) is a medical device that received FDA 510(k) clearance on 2017-08-09. The listed applicant is Nanjing Jin Bai HE Medical Apparatus Co., Ltd.. The 510(k) number is K170787.

When did Powered Wheelchair DYW30A(D09) receive FDA 510(k) clearance?

Powered Wheelchair DYW30A(D09) received FDA 510(k) clearance on 2017-08-09, under 510(k) number K170787.

Who is the listed applicant for Powered Wheelchair DYW30A(D09)?

The FDA 510(k) record lists Nanjing Jin Bai HE Medical Apparatus Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Powered Wheelchair DYW30A(D09)?

The FDA product code for Powered Wheelchair DYW30A(D09) is ITI.

Other records listing Nanjing Jin Bai HE Medical Apparatus Co., Ltd. as applicant

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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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