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FDA 510(k)

Manual Wheelchair (A006)

K-Number: K231110 · 2023-06-16

ApplicantNingbo Shenyu Medical Equipment Co.,Ltd
Decision Date2023-06-16
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Manual Wheelchair (A006) 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 2023-06-16 under 510(k) number K231110. 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 (A006)?

Manual Wheelchair (A006) is a medical device that received FDA 510(k) clearance on 2023-06-16. The listed applicant is Ningbo Shenyu Medical Equipment Co.,Ltd. The 510(k) number is K231110.

When did Manual Wheelchair (A006) receive FDA 510(k) clearance?

Manual Wheelchair (A006) received FDA 510(k) clearance on 2023-06-16, under 510(k) number K231110.

Who is the listed applicant for Manual Wheelchair (A006)?

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 (A006)?

The FDA product code for Manual Wheelchair (A006) 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.

K253599Electric Wheelchair (W-A807, W-A807L)K252517Manual Wheelchair (SYIV100A008)K201461Manual Wheelchair, Model A011

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.

K261571Manual Wheelchair (H008, PCK7)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.K252370GEN 4 JOY WheelchairFree Wheelchair MissionK261076Caregiver-assisted wheelchair (MS02);Caregiver-assisted wheelchair (MA02)GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd.K261075Manual Wheelchair (MS01);Manual Wheelchair (MA01)GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd.K260849ICON 35; ICON 45; ICON 60; ICON 30FAFRehasense USA, Inc.K260642Manual Wheelchair (LW01108)Anhui Longway Medical Technology Co., Ltd.

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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