Decision Date2020-09-15
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
Massage Compression Boots is the device name listed in this FDA 510(k) record. The listed applicant is Jkh USA, LLC. It received FDA 510(k) clearance on 2020-09-15 under 510(k) number K201645. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Massage Compression Boots?
Massage Compression Boots is a medical device that received FDA 510(k) clearance on 2020-09-15. The listed applicant is Jkh USA, LLC. The 510(k) number is K201645.
When did Massage Compression Boots receive FDA 510(k) clearance?
Massage Compression Boots received FDA 510(k) clearance on 2020-09-15, under 510(k) number K201645.
Who is the listed applicant for Massage Compression Boots?
The FDA 510(k) record lists Jkh USA, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Massage Compression Boots?
The FDA product code for Massage Compression Boots is IRP.
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Official Source
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