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)

Manual Wheelchair (H008, PCK7)

K-Number: K261571 · 2026-08-06

ApplicantJiangsu Yuyue Medical Equipment & Supply Co., Ltd.
Decision Date2026-08-06
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Manual Wheelchair (H008, PCK7) is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. It received FDA 510(k) clearance on 2026-08-06 under 510(k) number K261571. 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 (H008, PCK7)?

Manual Wheelchair (H008, PCK7) is a medical device that received FDA 510(k) clearance on 2026-08-06. The listed applicant is Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. The 510(k) number is K261571.

When did Manual Wheelchair (H008, PCK7) receive FDA 510(k) clearance?

Manual Wheelchair (H008, PCK7) received FDA 510(k) clearance on 2026-08-06, under 510(k) number K261571.

Who is the listed applicant for Manual Wheelchair (H008, PCK7)?

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

What is the FDA product code for Manual Wheelchair (H008, PCK7)?

The FDA product code for Manual Wheelchair (H008, PCK7) is IOR.

Other records listing Jiangsu Yuyue Medical Equipment & Supply 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.

K252779YUWELL® Electronic Blood Pressure Monitor (YE630CR)K253228YUWELL® Electronic Blood Pressure Monitor (YE650AR)K252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)K242736Portable Oxygen Concentrator (Spirit-3)K250878YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)K213825Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A

View all 13 devices →

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.

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.K260295Helio Kids; Apex PMotion Composites

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.

↑