510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PIAClass II

Vibrator For Climax Control Of Premature Ejaculation

21 CFR 876.5025 / Gastroenterology, Urology
FDA source (opens on fda.gov)

PIA is the FDA product code for Vibrator For Climax Control Of Premature Ejaculation, a class II device type, regulated under 21 CFR 876.5025. FDA's definition for this code reads: "Vibrator for climax control training for the treatment of premature ejaculation". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
PIA
Device name
Vibrator For Climax Control Of Premature Ejaculation
FDA definition
Vibrator for climax control training for the treatment of premature ejaculation.
Regulation
21 CFR 876.5025
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code PIA

By decision year
1 clearance under product code PIA with a decision year between 2015 and 2015, 2015 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PIA by decision year
YearClearances
20151

Applicants with the most clearances

Product code PIA
Applicants holding the most 510(k) clearances under product code PIA
ApplicantClearances
Ergon Medical, Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code