APEX 手动轮椅
K号: K161425 · 2016-12-05
广告
决定日期2016-12-05
产品代码IOR
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
APEX Manual Wheelchair is the device name listed in this FDA 510(k) record. The listed applicant is Motion Composites. It received FDA 510(k) clearance on 2016-12-05 under 510(k) number K161425. 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 APEX Manual Wheelchair?
APEX Manual Wheelchair is a medical device that received FDA 510(k) clearance on 2016-12-05. The listed applicant is Motion Composites. The 510(k) number is K161425.
When did APEX Manual Wheelchair receive FDA 510(k) clearance?
APEX Manual Wheelchair received FDA 510(k) clearance on 2016-12-05, under 510(k) number K161425.
Who is the listed applicant for APEX Manual Wheelchair?
The FDA 510(k) record lists Motion Composites as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for APEX Manual Wheelchair?
The FDA product code for APEX Manual Wheelchair is IOR.
相关临床试验
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。
列明Motion Composites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。
相关器械（代码：IOR）
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。
K253762ErgoSteel（ES0001/696）Strongback Mobility AG C/O Blueaudit GmbHK261919多功能轮椅（YJ-059）Zhenjiang Assure Medical Equipment Co., Ltd.K260144倾斜轮椅（YJ-013L）Zhenjiang Assure Medical Equipment Co., Ltd.K260141减重重型轮椅（YJ-010V，YJ-010C）Zhenjiang Assure Medical Equipment Co., Ltd.K260145YJ-K1K2 轮椅（YJ-013F）Zhenjiang Assure Medical Equipment Co., Ltd.K261571手动轮椅（H008，PCK7）Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
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。
广告