Decision Date2019-09-19
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
ProPerformance Recovery System is the device name listed in this FDA 510(k) record. The listed applicant is Menlo Brands, LLC. It received FDA 510(k) clearance on 2019-09-19 under 510(k) number K192252. 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 ProPerformance Recovery System?
ProPerformance Recovery System is a medical device that received FDA 510(k) clearance on 2019-09-19. The listed applicant is Menlo Brands, LLC. The 510(k) number is K192252.
When did ProPerformance Recovery System receive FDA 510(k) clearance?
ProPerformance Recovery System received FDA 510(k) clearance on 2019-09-19, under 510(k) number K192252.
Who is the listed applicant for ProPerformance Recovery System?
The FDA 510(k) record lists Menlo Brands, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ProPerformance Recovery System?
The FDA product code for ProPerformance Recovery System is IRP.
Related Devices (Code: IRP)
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.