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FDA 510(k)

Athena 190

K-Number: K173360 · 2018-05-17

ApplicantMedical Rehab Products, LLC
Decision Date2018-05-17
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Athena 190 is the device name listed in this FDA 510(k) record. The listed applicant is Medical Rehab Products, LLC. It received FDA 510(k) clearance on 2018-05-17 under 510(k) number K173360. 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 Athena 190?

Athena 190 is a medical device that received FDA 510(k) clearance on 2018-05-17. The listed applicant is Medical Rehab Products, LLC. The 510(k) number is K173360.

When did Athena 190 receive FDA 510(k) clearance?

Athena 190 received FDA 510(k) clearance on 2018-05-17, under 510(k) number K173360.

Who is the listed applicant for Athena 190?

The FDA 510(k) record lists Medical Rehab Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Athena 190?

The FDA product code for Athena 190 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

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

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