DeviceClearance

Product code PIA— Gastroenterology, Urology

PROLONG

Classification name
Vibrator For Climax Control Of Premature Ejaculation
Device class
Class 2
Regulation
21 CFR 876.5025
Advisory panel
Gastroenterology, Urology
Total cleared
1
First cleared
Most recent

FDA classification definition

“Vibrator for climax control training for the treatment of premature ejaculation.”

— U.S. Food and Drug Administration, device classification record for product code PIA under 21 CFR 876.5025, via openFDA

Market context for product code PIA

FDA has cleared 1 device under product code PIA, all in 2015, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code PIA

Recent clearances under product code PIA

Data sourced from openFDA. This site is unofficial and independent of the FDA.