FDA 510(k)

电动轮椅（Panda 10）；电动轮椅（Panda 12）

K号: K240079 · 2024-08-09

决定日期2024-08-09

产品代码ITI

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决定实质等同

器械摘要

Electric Wheelchair (Panda 10); Electric Wheelchair (Panda 12) is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Ideal Medical Co., Ltd.. It received FDA 510(k) clearance on 2024-08-09 under 510(k) number K240079. 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 Electric Wheelchair (Panda 10); Electric Wheelchair (Panda 12)?

Electric Wheelchair (Panda 10); Electric Wheelchair (Panda 12) is a medical device that received FDA 510(k) clearance on 2024-08-09. The listed applicant is Suzhou Ideal Medical Co., Ltd.. The 510(k) number is K240079.

When did Electric Wheelchair (Panda 10); Electric Wheelchair (Panda 12) receive FDA 510(k) clearance?

Electric Wheelchair (Panda 10); Electric Wheelchair (Panda 12) received FDA 510(k) clearance on 2024-08-09, under 510(k) number K240079.

Who is the listed applicant for Electric Wheelchair (Panda 10); Electric Wheelchair (Panda 12)?

The FDA 510(k) record lists Suzhou Ideal Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Electric Wheelchair (Panda 10); Electric Wheelchair (Panda 12)?

The FDA product code for Electric Wheelchair (Panda 10); Electric Wheelchair (Panda 12) is ITI.

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。

电动轮椅（Panda 10）；电动轮椅（Panda 12）

器械摘要

常见问题

相关临床试验

相关器械（代码：ITI）

官方来源