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FDA 510(k)

Manual Wheelchair, Model A011

K-Number: K201461 · 2021-05-21

ApplicantNingbo Shenyu Medical Equipment Co.,Ltd
Decision Date2021-05-21
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Manual Wheelchair, Model A011 is a medical device manufactured by Ningbo Shenyu Medical Equipment Co.,Ltd. It received FDA 510(k) clearance on 2021-05-21 under approval 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. It is manufactured by Ningbo Shenyu Medical Equipment Co.,Ltd. The 510(k) number is K201461.

When was Manual Wheelchair, Model A011 approved by the FDA?

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

What company makes Manual Wheelchair, Model A011?

Manual Wheelchair, Model A011 is manufactured by Ningbo Shenyu Medical Equipment Co.,Ltd.

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

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

Related Clinical Trials

NCT03053791 Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait RECRUITING NCT05776030 Multi-speed Ergonomic Wheelchair RECRUITING NCT04668326 Mobile Manual Standing Wheelchair for SCI COMPLETED NCT07491068 The Accuracy and Efficacy of Large Language Model Written Hospital Course Summaries NOT_YET_RECRUITING NCT07357480 Comparison of Target-Controlled and Manual Total Intravenous Anesthesia in Supratentorial Surgery RECRUITING

Related PubMed Literature

PMID: 41915420 Analysis Model for Infant Incubator Adverse Events Using Retrieval-Augmented Generation Combined With Dual-Adapter Fine-Tuning: Development and Evaluation Study. JMIR medical informatics (2026) PMID: 40006413 Data Reconstruction Methods in Multi-Feature Fusion CNN Model for Enhanced Human Activity Recognition. Sensors (Basel, Switzerland) (2025)

Other Devices by Ningbo Shenyu Medical Equipment Co.,Ltd

K231110Manual Wheelchair (A006) K252517Manual Wheelchair (SYIV100A008) K253599Electric Wheelchair (W-A807, W-A807L)

Related Devices (Code: IOR)

K162696Kuschall Advance Manual WheelchairInvacare Corporation K162686Kuschall Champion Manual WheelchairInvacare Corporation K162692Kuschall K-Series Attract Manual WheelchairInvacare Corporation K161425APEX Manual WheelchairMotion Composites K153328SUNCO Mechanical Wheelchair, model SKW-9003Danyang Sunco Machinery Co., Ltd. K151492KuduR82 A/S

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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