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FDA 510(k)

LEva Pelvic Digital Health System

K-Number: K192270 · 2019-11-22

ApplicantRenovia, Inc.
Decision Date2019-11-22
Product CodeHIR
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LEva Pelvic Digital Health System is a medical device manufactured by Renovia, Inc.. It received FDA 510(k) clearance on 2019-11-22 under approval number K192270. 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 Digital Health System?

LEva Pelvic Digital Health System is a medical device that received FDA 510(k) clearance on 2019-11-22. It is manufactured by Renovia, Inc.. The 510(k) number is K192270.

When was LEva Pelvic Digital Health System approved by the FDA?

LEva Pelvic Digital Health System received FDA 510(k) clearance on 2019-11-22, under approval number K192270.

What company makes LEva Pelvic Digital Health System?

LEva Pelvic Digital Health System is manufactured by Renovia, Inc..

What is the FDA product code for LEva Pelvic Digital Health System?

The FDA product code for LEva Pelvic Digital Health System is HIR.

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Related PubMed Literature

PMID: 42174919 Automating Safety Surveillance for Software-Based Medical Devices: Insights from FDA MAUDE Data. Studies in health technology and informatics (2026) PMID: 42067025 Regulating cybersecurity in digital health: A comparative policy analysis of the USA, EU, and India. Annales pharmaceutiques francaises (2026) PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026) PMID: 42037982 Ethical, legal, and social implications of AI-enabled digital therapeutics: A comparative analysis of risk-based regulatory frameworks in the European Union and Japan. Digital health (2026)

Other Devices by Renovia, Inc.

K180637leva Pelvic Floor Trainer K212495Leva Pelvic 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. K193364Intimate Rose Kegel Exercise SystemPlus EV Holdings Dba Intimate Rose K200409Pelvital SystemPelvital USA, Inc.

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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