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510(k) K213913

leva Pelvic Health System by Renovia, Inc. — Product Code HIR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 2022
Date Received
December 15, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Perineometer
Device Class
Class II
Regulation Number
884.1425
Review Panel
GU
Submission Type

Other clearances by Renovia, Inc.

  • K212495 — Leva Pelvic Health System (September 8, 2021)
  • K192270 — LEva Pelvic Digital Health System (November 22, 2019)
  • K180637 — leva Pelvic Floor Trainer (April 4, 2018)

Other clearances for product code HIR

  • K240805 — Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5) (August 1, 2024)
  • K231875 — Vaginal Tactile Ultrasound Imager (February 22, 2024)
  • K233362 — Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0) (December 29, 2023)
  • K231780 — Perifit Care+ (December 20, 2023)
  • K221476 — Perifit (February 10, 2023)
  • K212655 — Flyte (September 21, 2021)
  • K212495 — Leva Pelvic Health System (September 8, 2021)
  • K210764 — Flyte (April 13, 2021)
  • K193364 — Intimate Rose Kegel Exercise System (August 24, 2020)
  • K200409 — Pelvital System (July 10, 2020)