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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 a medical device manufactured by Renovia, Inc.. It received FDA 510(k) clearance on 2021-09-08 under approval 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. It is manufactured by Renovia, Inc.. The 510(k) number is K212495.

When was Leva Pelvic Health System approved by the FDA?

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

What company makes Leva Pelvic Health System?

Leva Pelvic Health System is manufactured by Renovia, Inc..

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

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

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Related PubMed Literature

PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026) PMID: 41915995 Inflammation-metabolism-fibrosis axis: mechanisms and therapeutic strategies targeting the chronicity of pelvic inflammatory disease. International immunopharmacology (2026) PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 41879133 Medical Device Regulation - Who Does the FDA Serve? The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026)

Other Devices by Renovia, Inc.

K180637leva Pelvic Floor Trainer K192270LEva Pelvic Digital Health System K213913leva Pelvic Health System

Related Devices (Code: HIR)

K160758PeriCoach OTCAnalytica, Ltd. K171896Feminine Personal Trainer (FPT)Ralston Group K162689Vibrance Pelvic TrainerBioinfinity (M) Sdn. Bhd. K180637leva Pelvic Floor TrainerRenovia, Inc. K192270LEva Pelvic Digital Health SystemRenovia, Inc. K193364Intimate Rose Kegel Exercise SystemPlus EV Holdings Dba Intimate Rose

Official Source

View on FDA Database →

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

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