PeriCoach— 510(k) K143580

Substantially Equivalent

Analytica, Ltd.

FDA 510(k) clearance K143580 for PeriCoach, Substantially Equivalent on 2015-03-18. Applicant: Analytica, Ltd.. Device class: 2.

Clearance details

Applicant: Analytica, Ltd.
Product code: Code HIR
Device class: Class 2
Regulation: 21 CFR 884.1425
Advisory panel: Obstetrics/Gynecology
Date received: 2014-12-18
Decision date: 2015-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brisbane, AU

Download summary PDF View on FDA.gov ↗

Recent devices under product code HIR

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 Analytica, Ltd.

K160758 — PeriCoach OTC2016-07-11

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