FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

This document is a 510(k) clearance letter from the FDA for a Vacuum Erection System. It does not contain information about acceptance criteria or a study proving that the device meets those criteria. Such information would typically be found in the manufacturer's 510(k) submission, which is not provided here.

Therefore, I cannot provide the requested information. The document explicitly states that the FDA "reviewed your Section 510(k) notification of intent to market the device...and we have determined the device is substantially equivalent...to devices marketed in interstate commerce prior to May 28, 1976." This indicates a substantial equivalence pathway, not a performance study against specific acceptance criteria.

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K Number

K936312

Device Name

MANUAL MASSAGE ROLLER

Manufacturer

MCKENNA & CUNEO

Date Cleared

1996-01-29

(794 days)

Product Code