FDA 510(k)

ShockPhysio 移动式（型号 SW3200 Basic）

K号: K240358 · 2024-06-05

申请人Shenzhen Dongdixin Technology Co., Ltd.

决定日期2024-06-05

产品代码ISA

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决定实质等同

器械摘要

ShockPhysio Mobile (model SW3200 Basic) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Dongdixin Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-06-05 under 510(k) number K240358. The device is classified under product code ISA. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ShockPhysio Mobile (model SW3200 Basic)?

ShockPhysio Mobile (model SW3200 Basic) is a medical device that received FDA 510(k) clearance on 2024-06-05. The listed applicant is Shenzhen Dongdixin Technology Co., Ltd.. The 510(k) number is K240358.

When did ShockPhysio Mobile (model SW3200 Basic) receive FDA 510(k) clearance?

ShockPhysio Mobile (model SW3200 Basic) received FDA 510(k) clearance on 2024-06-05, under 510(k) number K240358.

Who is the listed applicant for ShockPhysio Mobile (model SW3200 Basic)?

The FDA 510(k) record lists Shenzhen Dongdixin Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ShockPhysio Mobile (model SW3200 Basic)?

The FDA product code for ShockPhysio Mobile (model SW3200 Basic) is ISA.

列明Shenzhen Dongdixin Technology Co., Ltd.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。

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