Perifit— 510(k) K221476

Substantially Equivalent

X6 Innovations

FDA 510(k) clearance K221476 for Perifit, Substantially Equivalent on 2023-02-10. Applicant: X6 Innovations. Device class: 2.

Clearance details

Applicant: X6 Innovations
Product code: Code HIR
Device class: Class 2
Regulation: 21 CFR 884.1425
Advisory panel: Obstetrics/Gynecology
Date received: 2022-05-20
Decision date: 2023-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paris, FR

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 X6 Innovations

K231785 — Perifit Pump2024-01-26

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