Home / 510(k) Clearances / K140780

510(k) K140780

KEGEL SMART, KEGELSMART PEARL by Regulatory Insight, Inc. — Product Code HIR

K140780 is an FDA 510(k) premarket notification submitted by Regulatory Insight, Inc. for the device "KEGEL SMART, KEGELSMART PEARL". The FDA issued a decision of Substantially Equivalent on September 10, 2014. The device falls under product code HIR (Perineometer), a Class II device regulated under 21 CFR 884.1425. Regulatory Insight, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 2014
Date Received
March 28, 2014
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 Regulatory Insight, Inc.

  • K112505 — ETHEREA (April 6, 2012)
  • K020100 — SL 803, SL 804, SL 807, SL 809, SL 506, SL 501, SL 805 AND SL 801 MECHANICAL WHE (March 8, 2002)
  • K020094 — EN 600-658, EN 600-666, EN 600-664, EN 600-690, EN 600-651, EN 600-663, EN 600-6 (March 8, 2002)

Other clearances for product code HIR

  • K252748 — Pelvic Floor Exerciser (PF01) (April 27, 2026)
  • 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)

FDA data resources