ICON 35；ICON 45；ICON 60；ICON 30FAF
K号: K260849 · 2026-06-11
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决定日期2026-06-11
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
ICON 35; ICON 45; ICON 60; ICON 30FAF is the device name listed in this FDA 510(k) record. The listed applicant is Rehasense USA, Inc.. It received FDA 510(k) clearance on 2026-06-11 under 510(k) number K260849. 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 ICON 35; ICON 45; ICON 60; ICON 30FAF?
ICON 35; ICON 45; ICON 60; ICON 30FAF is a medical device that received FDA 510(k) clearance on 2026-06-11. The listed applicant is Rehasense USA, Inc.. The 510(k) number is K260849.
When did ICON 35; ICON 45; ICON 60; ICON 30FAF receive FDA 510(k) clearance?
ICON 35; ICON 45; ICON 60; ICON 30FAF received FDA 510(k) clearance on 2026-06-11, under 510(k) number K260849.
Who is the listed applicant for ICON 35; ICON 45; ICON 60; ICON 30FAF?
The FDA 510(k) record lists Rehasense USA, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ICON 35; ICON 45; ICON 60; ICON 30FAF?
The FDA product code for ICON 35; ICON 45; ICON 60; ICON 30FAF is IOR.
相关器械（代码：IOR）
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官方来源
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