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510(k) K945937

TE-800 PELVIC FLOOR EXERCISER by Myo/Kinetic Systems, Inc. — Product Code HIR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1995
Date Received
December 5, 1994
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 Myo/Kinetic Systems, Inc.

  • K945292 — TS-700P CONTROL XP ELECTRICAL STIMULATOR (April 12, 1995)
  • K944972 — URO-GRAM CYSTOMRTROGRAM WITH UROFLOWMETRY (March 8, 1995)
  • K936041 — UROGRAM CYSTOMETROGRAM (April 18, 1994)
  • K932611 — NEUROMUSCULAR STIMULATOR (January 31, 1994)
  • K932764 — THERAPEUTIC STIMULATOR 300(TS-300) & 300P(TS-300P) (October 1, 1993)
  • K932399 — THERAPEUTIC STIM 200 (TS-200)/200P (TS-200P) (August 11, 1993)
  • K914904 — THERAPEUTIC STIMULATOR 2100 (TS-2100) (April 28, 1992)

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)
  • K210764 — Flyte (April 13, 2021)
  • K193364 — Intimate Rose Kegel Exercise System (August 24, 2020)