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FDA 510(k)

Manual Wheelchair SIVFH2A102

K-Number: K190534 · 2019-05-29

ApplicantJiangsu Horizon Medical Science & Technology Co., Ltd.
Decision Date2019-05-29
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Manual Wheelchair SIVFH2A102 is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Horizon Medical Science & Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-05-29 under 510(k) number K190534. 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 SIVFH2A102?

Manual Wheelchair SIVFH2A102 is a medical device that received FDA 510(k) clearance on 2019-05-29. The listed applicant is Jiangsu Horizon Medical Science & Technology Co., Ltd.. The 510(k) number is K190534.

When did Manual Wheelchair SIVFH2A102 receive FDA 510(k) clearance?

Manual Wheelchair SIVFH2A102 received FDA 510(k) clearance on 2019-05-29, under 510(k) number K190534.

Who is the listed applicant for Manual Wheelchair SIVFH2A102?

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

What is the FDA product code for Manual Wheelchair SIVFH2A102?

The FDA product code for Manual Wheelchair SIVFH2A102 is IOR.

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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