FDA 510(k)

XT系列电动轮椅（XT2），XT系列电动轮椅（XT4）

K号: K233877 · 2024-03-04

决定日期2024-03-04

产品代码ITI

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决定实质等同

器械摘要

XT Series Power Wheelchair (XT2), XT Series Power Wheelchair (XT4) is the device name listed in this FDA 510(k) record. The listed applicant is Magic Mobility. It received FDA 510(k) clearance on 2024-03-04 under 510(k) number K233877. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the XT Series Power Wheelchair (XT2), XT Series Power Wheelchair (XT4)?

XT Series Power Wheelchair (XT2), XT Series Power Wheelchair (XT4) is a medical device that received FDA 510(k) clearance on 2024-03-04. The listed applicant is Magic Mobility. The 510(k) number is K233877.

When did XT Series Power Wheelchair (XT2), XT Series Power Wheelchair (XT4) receive FDA 510(k) clearance?

XT Series Power Wheelchair (XT2), XT Series Power Wheelchair (XT4) received FDA 510(k) clearance on 2024-03-04, under 510(k) number K233877.

Who is the listed applicant for XT Series Power Wheelchair (XT2), XT Series Power Wheelchair (XT4)?

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

What is the FDA product code for XT Series Power Wheelchair (XT2), XT Series Power Wheelchair (XT4)?

The FDA product code for XT Series Power Wheelchair (XT2), XT Series Power Wheelchair (XT4) is ITI.

列明Magic Mobility为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K213090Frontier系列电动轮椅 K211574Extreme X8 K203083Magic 360 Power Wheelchair

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。