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 a medical device manufactured by Nanjing Jin Bai HE Medical Apparatus Co., Ltd.. It received FDA 510(k) clearance on 2017-08-09 under approval 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. It is manufactured by Nanjing Jin Bai HE Medical Apparatus Co., Ltd.. The 510(k) number is K170787.

When was Powered Wheelchair DYW30A(D09) approved by the FDA?

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

What company makes Powered Wheelchair DYW30A(D09)?

Powered Wheelchair DYW30A(D09) is manufactured by Nanjing Jin Bai HE Medical Apparatus Co., Ltd..

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

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

Related Clinical Trials

NCT05776030 Multi-speed Ergonomic Wheelchair RECRUITING

Other Devices by Nanjing Jin Bai HE Medical Apparatus Co., Ltd.

K201196Scooter (Model: FDB01)

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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.