FDA 510(k)

电动轮椅（JJW-7002, JJW-7003）

K号: K253849 · 2026-03-20

决定日期2026-03-20

产品代码ITI

咨询委员会PM 请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。

决定实质等同

器械摘要

Electric wheelchair (JJW-7002, JJW-7003) is the device name listed in this FDA 510(k) record. The listed applicant is ZheJiang J&J Mobility Co., Ltd.. It received FDA 510(k) clearance on 2026-03-20 under 510(k) number K253849. 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 (JJW-7002, JJW-7003)?

Electric wheelchair (JJW-7002, JJW-7003) is a medical device that received FDA 510(k) clearance on 2026-03-20. The listed applicant is ZheJiang J&J Mobility Co., Ltd.. The 510(k) number is K253849.

When did Electric wheelchair (JJW-7002, JJW-7003) receive FDA 510(k) clearance?

Electric wheelchair (JJW-7002, JJW-7003) received FDA 510(k) clearance on 2026-03-20, under 510(k) number K253849.

Who is the listed applicant for Electric wheelchair (JJW-7002, JJW-7003)?

The FDA 510(k) record lists ZheJiang J&J Mobility Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Electric wheelchair (JJW-7002, JJW-7003)?

The FDA product code for Electric wheelchair (JJW-7002, JJW-7003) is ITI.

列明ZheJiang J&J Mobility 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。

K240563电动轮椅 (JJW-6001)

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。