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FDA 510(k)

Bambino 3, S3 and S3 Swing, U3 and U3 Light, X

K-Number: K220698 · 2023-02-16

ApplicantPanthera AB
Decision Date2023-02-16
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Bambino 3, S3 and S3 Swing, U3 and U3 Light, X is the device name listed in this FDA 510(k) record. The listed applicant is Panthera AB. It received FDA 510(k) clearance on 2023-02-16 under 510(k) number K220698. 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 Bambino 3, S3 and S3 Swing, U3 and U3 Light, X?

Bambino 3, S3 and S3 Swing, U3 and U3 Light, X is a medical device that received FDA 510(k) clearance on 2023-02-16. The listed applicant is Panthera AB. The 510(k) number is K220698.

When did Bambino 3, S3 and S3 Swing, U3 and U3 Light, X receive FDA 510(k) clearance?

Bambino 3, S3 and S3 Swing, U3 and U3 Light, X received FDA 510(k) clearance on 2023-02-16, under 510(k) number K220698.

Who is the listed applicant for Bambino 3, S3 and S3 Swing, U3 and U3 Light, X?

The FDA 510(k) record lists Panthera AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bambino 3, S3 and S3 Swing, U3 and U3 Light, X?

The FDA product code for Bambino 3, S3 and S3 Swing, U3 and U3 Light, X 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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