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)

Kudu

K-Number: K151492 · 2016-05-20

ApplicantR82 A/S
Decision Date2016-05-20
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Kudu is the device name listed in this FDA 510(k) record. The listed applicant is R82 A/S. It received FDA 510(k) clearance on 2016-05-20 under 510(k) number K151492. 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 Kudu?

Kudu is a medical device that received FDA 510(k) clearance on 2016-05-20. The listed applicant is R82 A/S. The 510(k) number is K151492.

When did Kudu receive FDA 510(k) clearance?

Kudu received FDA 510(k) clearance on 2016-05-20, under 510(k) number K151492.

Who is the listed applicant for Kudu?

The FDA 510(k) record lists R82 A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Kudu?

The FDA product code for Kudu is IOR.

Other records listing R82 A/S 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.

K100084MULTI FRAME WHEELCHAIRK061810COUGAR WHEELCHAIRK033460CHEETAH WHEELCHAIRK030882RABBIT MOBILE STANDING FRAME

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.

K253762ErgoSteel (ES0001/696)Strongback Mobility AG C/O Blueaudit GmbHK261919Multifunctional wheelchair (YJ-059)Zhenjiang Assure Medical Equipment Co., Ltd.K260141Bariatric Heavy Duty Wheelchair (YJ-010V, YJ-010C)Zhenjiang Assure Medical Equipment Co., Ltd.K260145YJ-K1K2 Wheelchair (YJ-013F)Zhenjiang Assure Medical Equipment Co., Ltd.K260144Reclining wheelchair (YJ-013L)Zhenjiang Assure Medical Equipment Co., Ltd.K261571Manual Wheelchair (H008, PCK7)Jiangsu Yuyue Medical Equipment & Supply 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.

↑