FDA 510(k)

Invacare Tracer SX5 手动轮椅，Invacare Tracer IV 重型/加宽手动轮椅

K号: K162621 · 2017-04-17

决定日期2017-04-17

产品代码IOR

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决定实质等同

器械摘要

Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual Wheelchair is the device name listed in this FDA 510(k) record. The listed applicant is Invacare Corporation. It received FDA 510(k) clearance on 2017-04-17 under 510(k) number K162621. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual Wheelchair?

Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual Wheelchair is a medical device that received FDA 510(k) clearance on 2017-04-17. The listed applicant is Invacare Corporation. The 510(k) number is K162621.

When did Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual Wheelchair receive FDA 510(k) clearance?

Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual Wheelchair received FDA 510(k) clearance on 2017-04-17, under 510(k) number K162621.

Who is the listed applicant for Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual Wheelchair?

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

What is the FDA product code for Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual Wheelchair?

The FDA product code for Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual Wheelchair is IOR.

列明Invacare Corporation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。

K203210Invacare Platinum 5NXG 氧气浓缩器 K202379Invacare AVIVA Storm RX 动力轮椅 K200890Invacare Perfecto2V 氧气浓缩器 K192216Invacare AVIVA FX 动力轮椅，型号：IFX-20MP K191159单电池组浓缩器，带肩带携带包，背包肩带，A，POC1 USB 蓝牙适配器，POC1 Invacare 移动医疗应用程序配件，用于 iOS 和 Android 设备，Invacare Platinum 移动制氧机带连接功能 K182946Invacare TDX SP2-HD 配有船长座椅

查看所有 14 个设备 →

官方来源

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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。