Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Powered Wheelchair (NXN20-208, NXN20-211)

K-Number: K241603 · 2024-11-20

ApplicantZhejiang Nysin Medical Co., Ltd.
Decision Date2024-11-20
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Powered Wheelchair (NXN20-208, NXN20-211) is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Nysin Medical Co., Ltd.. It received FDA 510(k) clearance on 2024-11-20 under 510(k) number K241603. 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 (NXN20-208, NXN20-211)?

Powered Wheelchair (NXN20-208, NXN20-211) is a medical device that received FDA 510(k) clearance on 2024-11-20. The listed applicant is Zhejiang Nysin Medical Co., Ltd.. The 510(k) number is K241603.

When did Powered Wheelchair (NXN20-208, NXN20-211) receive FDA 510(k) clearance?

Powered Wheelchair (NXN20-208, NXN20-211) received FDA 510(k) clearance on 2024-11-20, under 510(k) number K241603.

Who is the listed applicant for Powered Wheelchair (NXN20-208, NXN20-211)?

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

What is the FDA product code for Powered Wheelchair (NXN20-208, NXN20-211)?

The FDA product code for Powered Wheelchair (NXN20-208, NXN20-211) is ITI.

Other records listing Zhejiang Nysin Medical 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.

K252275Electric Scooter (DDF100)K241529Powered Wheelchair (NXN20-209)K241379Powered Wheelchair (NXN20-205, NXN20-205M)

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑