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510(k) K240805

Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5) by Pelvital USA, Inc. — Product Code HIR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2024
Date Received
March 25, 2024
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 Pelvital USA, Inc.

  • K233362 — Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0) (December 29, 2023)
  • K212655 — Flyte (September 21, 2021)
  • K210764 — Flyte (April 13, 2021)
  • K200409 — Pelvital System (July 10, 2020)

Other clearances for product code HIR

  • 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)
  • K213913 — leva Pelvic Health System (June 30, 2022)
  • 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)