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FDA 510(k)

Leva Pelvic Health System

K-Number: K212495 · 2021-09-08

ApplicantRenovia, Inc.
Decision Date2021-09-08
Product CodeHIR
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Leva Pelvic Health System is the device name listed in this FDA 510(k) record. The listed applicant is Renovia, Inc.. It received FDA 510(k) clearance on 2021-09-08 under 510(k) number K212495. The device is classified under product code HIR. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Leva Pelvic Health System?

Leva Pelvic Health System is a medical device that received FDA 510(k) clearance on 2021-09-08. The listed applicant is Renovia, Inc.. The 510(k) number is K212495.

When did Leva Pelvic Health System receive FDA 510(k) clearance?

Leva Pelvic Health System received FDA 510(k) clearance on 2021-09-08, under 510(k) number K212495.

Who is the listed applicant for Leva Pelvic Health System?

The FDA 510(k) record lists Renovia, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Leva Pelvic Health System?

The FDA product code for Leva Pelvic Health System is HIR.

Other records listing Renovia, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K213913leva Pelvic Health SystemK192270LEva Pelvic Digital Health SystemK180637leva Pelvic Floor Trainer

Related Devices (Code: HIR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252748Pelvic Floor Exerciser (PF01)Hunan Accurate Bio-Medical Technology Co., Ltd.K240805Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)Pelvital USA, Inc.K231875Vaginal Tactile Ultrasound ImagerAdvanced Tactile Imaging, Inc.K233362Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)Pelvital USA, Inc.K231780Perifit Care+X6 InnovationsK221476PerifitX6 Innovations

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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