VIBRANCE KEGEL DEVICE (VKD)— 510(k) K141893

Name: FDA 510(k) clearance K141893
Creator: U.S. Food and Drug Administration
Published: 2014-12-18

Substantially Equivalent

Bioinfinity (M) Sdn. Bhd.

FDA 510(k) clearance K141893 for VIBRANCE KEGEL DEVICE (VKD), Substantially Equivalent on 2014-12-18. 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: 2014-07-14
Decision date: 2014-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HIR

view all

K252748 — Pelvic Floor Exerciser (PF01)2026-04-27
K240805 — Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)2024-08-01
K231875 — Vaginal Tactile Ultrasound Imager2024-02-22
K233362 — Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)2023-12-29
K231780 — Perifit Care+2023-12-20

More clearances from Bioinfinity (M) Sdn. Bhd.

view all

K162689 — Vibrance Pelvic Trainer2017-06-08

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