leva Pelvic Health System— 510(k) K213913

Substantially Equivalent

Renovia, Inc.

FDA 510(k) clearance K213913 for leva Pelvic Health System, Substantially Equivalent on 2022-06-30. Applicant: Renovia, Inc.. Device class: 2.

Clearance details

Applicant: Renovia, Inc.
Product code: Code HIR
Device class: Class 2
Regulation: 21 CFR 884.1425
Advisory panel: Obstetrics/Gynecology
Date received: 2021-12-15
Decision date: 2022-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boston, MA, US

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 Renovia, Inc.

K212495 — Leva Pelvic Health System2021-09-08
K192270 — LEva Pelvic Digital Health System2019-11-22
K180637 — leva Pelvic Floor Trainer2018-04-04

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