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FDA 510(k)

Manual Wheelchair, Model A011

K-Number: K201461 · 2021-05-21

Decision Date2021-05-21
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Manual Wheelchair, Model A011 is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Shenyu Medical Equipment Co.,Ltd. It received FDA 510(k) clearance on 2021-05-21 under 510(k) number K201461. 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 Manual Wheelchair, Model A011?

Manual Wheelchair, Model A011 is a medical device that received FDA 510(k) clearance on 2021-05-21. The listed applicant is Ningbo Shenyu Medical Equipment Co.,Ltd. The 510(k) number is K201461.

When did Manual Wheelchair, Model A011 receive FDA 510(k) clearance?

Manual Wheelchair, Model A011 received FDA 510(k) clearance on 2021-05-21, under 510(k) number K201461.

Who is the listed applicant for Manual Wheelchair, Model A011?

The FDA 510(k) record lists Ningbo Shenyu Medical Equipment Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Manual Wheelchair, Model A011?

The FDA product code for Manual Wheelchair, Model A011 is IOR.

Other records listing Ningbo Shenyu Medical Equipment Co.,Ltd as applicant

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.

Related Devices (Code: IOR)

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.

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.