FDA 510(k)

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

K-Number: K220698 · 2023-02-16

Decision Date2023-02-16

Product CodeIOR

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

Bambino 3, S3 and S3 Swing, U3 and U3 Light, X is a medical device manufactured by Panthera AB. It received FDA 510(k) clearance on 2023-02-16 under approval 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. It is manufactured by Panthera AB. The 510(k) number is K220698.

When was Bambino 3, S3 and S3 Swing, U3 and U3 Light, X approved by the FDA?

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

What company makes Bambino 3, S3 and S3 Swing, U3 and U3 Light, X?

Bambino 3, S3 and S3 Swing, U3 and U3 Light, X is manufactured by Panthera AB.

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)

K162696Kuschall Advance Manual WheelchairInvacare Corporation K162686Kuschall Champion Manual WheelchairInvacare Corporation K162692Kuschall K-Series Attract Manual WheelchairInvacare Corporation K161425APEX Manual WheelchairMotion Composites K153328SUNCO Mechanical Wheelchair, model SKW-9003Danyang Sunco Machinery Co., Ltd. K151492KuduR82 A/S

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.