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510(k) K210764

Flyte by Pelvital USA, Inc. — Product Code HIR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 2021
Date Received
March 15, 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)
  • K212655 — Flyte (September 21, 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)
  • K212655 — Flyte (September 21, 2021)
  • K212495 — Leva Pelvic Health System (September 8, 2021)
  • K193364 — Intimate Rose Kegel Exercise System (August 24, 2020)
  • K200409 — Pelvital System (July 10, 2020)