SUNTEC 机械轮椅，型号 ST-WL-1000
K号: K152878 · 2016-02-03
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决定日期2016-02-03
产品代码IOR
咨询委员会PM
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决定实质等同
器械摘要
SUNTEC Mechanical Wheelchair, model ST-WL-1000 is the device name listed in this FDA 510(k) record. The listed applicant is Danyang Suntec Auto Parts Co., Ltd.. It received FDA 510(k) clearance on 2016-02-03 under 510(k) number K152878. 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 SUNTEC Mechanical Wheelchair, model ST-WL-1000?
SUNTEC Mechanical Wheelchair, model ST-WL-1000 is a medical device that received FDA 510(k) clearance on 2016-02-03. The listed applicant is Danyang Suntec Auto Parts Co., Ltd.. The 510(k) number is K152878.
When did SUNTEC Mechanical Wheelchair, model ST-WL-1000 receive FDA 510(k) clearance?
SUNTEC Mechanical Wheelchair, model ST-WL-1000 received FDA 510(k) clearance on 2016-02-03, under 510(k) number K152878.
Who is the listed applicant for SUNTEC Mechanical Wheelchair, model ST-WL-1000?
The FDA 510(k) record lists Danyang Suntec Auto Parts Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SUNTEC Mechanical Wheelchair, model ST-WL-1000?
The FDA product code for SUNTEC Mechanical Wheelchair, model ST-WL-1000 is IOR.
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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。
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官方来源
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