Vibrance Pelvic Trainer— 510(k) K162689

Name: FDA 510(k) clearance K162689
Creator: U.S. Food and Drug Administration
Published: 2017-06-08

Substantially Equivalent

Bioinfinity (M) Sdn. Bhd.

FDA 510(k) clearance K162689 for Vibrance Pelvic Trainer, Substantially Equivalent on 2017-06-08. Applicant: Bioinfinity (M) Sdn. Bhd.. Device class: 2.

Clearance details

Applicant: Bioinfinity (M) Sdn. Bhd.
Product code: Code HIR
Device class: Class 2
Regulation: 21 CFR 884.1425
Advisory panel: Obstetrics/Gynecology
Date received: 2016-09-27
Decision date: 2017-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kepong, MY

Download summary PDF View on FDA.gov ↗

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