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510(k) K212655

Flyte by Pelvital USA, Inc. — Product Code HIR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 2021
Date Received
August 23, 2021
Clearance Type
Special
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.

  • K240805 — Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5) (August 1, 2024)
  • K233362 — Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0) (December 29, 2023)
  • K210764 — Flyte (April 13, 2021)
  • K200409 — Pelvital System (July 10, 2020)

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